Trial Outcomes & Findings for Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (NCT NCT03434028)
NCT ID: NCT03434028
Last Updated: 2023-07-06
Results Overview
The primary outcome was death from any cause before discharge home by day 90. Point estimates were from Kaplan-Meier curves. There were 109 deaths and 5 patients with censored data the restrictive fluid group and 116 deaths and 4 patients with censored data in the liberal group. We defined home as the same setting or a setting similar to the one where the patient resided before becoming ill. Thus, if a patient originated from a private residence and was discharged from the hospital to a rehabilitation setting, we assessed for vital status until return to the private residence.Vital status was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, review of obituaries, or information from the Centers for Disease Control and Prevention's National Death Index (NDI).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1563 participants
Primary outcome timeframe
From randomization to discharge home up to and including day 90.
Results posted on
2023-07-06
Participant Flow
Participant milestones
| Measure |
Restrictive Fluids
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Overall Study
STARTED
|
782
|
781
|
|
Overall Study
COMPLETED
|
782
|
781
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
Baseline characteristics by cohort
| Measure |
Restrictive Fluids
n=782 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=781 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
Total
n=1563 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 16 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
371 Participants
n=5 Participants
|
366 Participants
n=7 Participants
|
737 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
411 Participants
n=5 Participants
|
415 Participants
n=7 Participants
|
826 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
134 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
532 Participants
n=5 Participants
|
570 Participants
n=7 Participants
|
1102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
78 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
782 participants
n=5 Participants
|
781 participants
n=7 Participants
|
1563 participants
n=5 Participants
|
|
Hispanic or Latino ethnic group
yes
|
118 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Hispanic or Latino ethnic group
no
|
628 Participants
n=5 Participants
|
646 Participants
n=7 Participants
|
1274 Participants
n=5 Participants
|
|
Hispanic or Latino ethnic group
not reported
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sequential Organ Failure Assessment (SOFA) score
|
3.4 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Systolic Blood Pressure
|
93.2 mm Hg
STANDARD_DEVIATION 12 • n=5 Participants
|
93.8 mm Hg
STANDARD_DEVIATION 12.2 • n=7 Participants
|
93.5 mm Hg
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Time from meeting eligibility to randomization
|
61 minutes
n=5 Participants
|
60 minutes
n=7 Participants
|
61 minutes
n=5 Participants
|
|
Location at Randomization
Emergency Department
|
729 Participants
n=5 Participants
|
708 Participants
n=7 Participants
|
1437 Participants
n=5 Participants
|
|
Location at Randomization
ICU
|
44 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Location at Randomization
Other
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Volume of fluid administered before randomization
|
2050 mililiters
n=5 Participants
|
2050 mililiters
n=7 Participants
|
2050 mililiters
n=5 Participants
|
|
Coexisting Conditions
Diabetes · Yes
|
222 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
446 Participants
n=5 Participants
|
|
Coexisting Conditions
Diabetes · No
|
555 Participants
n=5 Participants
|
549 Participants
n=7 Participants
|
1104 Participants
n=5 Participants
|
|
Coexisting Conditions
Diabetes · No reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Coexisting Conditions
Chronic heart failure · Yes
|
99 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Coexisting Conditions
Chronic heart failure · No
|
678 Participants
n=5 Participants
|
694 Participants
n=7 Participants
|
1372 Participants
n=5 Participants
|
|
Coexisting Conditions
Chronic heart failure · No reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Coexisting Conditions
end-stage renal disease treated with hemodialysis · Yes
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Coexisting Conditions
end-stage renal disease treated with hemodialysis · No
|
744 Participants
n=5 Participants
|
733 Participants
n=7 Participants
|
1477 Participants
n=5 Participants
|
|
Coexisting Conditions
end-stage renal disease treated with hemodialysis · No reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to discharge home up to and including day 90.Population: There were 109 deaths and 5 patients with censored data the restrictive fluid group. There were 116 deaths and 4 patients with censored data in the liberal group. Point estimates from the Kaplan-Meier curve.
The primary outcome was death from any cause before discharge home by day 90. Point estimates were from Kaplan-Meier curves. There were 109 deaths and 5 patients with censored data the restrictive fluid group and 116 deaths and 4 patients with censored data in the liberal group. We defined home as the same setting or a setting similar to the one where the patient resided before becoming ill. Thus, if a patient originated from a private residence and was discharged from the hospital to a rehabilitation setting, we assessed for vital status until return to the private residence.Vital status was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, review of obituaries, or information from the Centers for Disease Control and Prevention's National Death Index (NDI).
Outcome measures
| Measure |
Restrictive Fluids
n=782 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=781 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Death Before Discharge Home by Day 90
|
14 percentage of participants
Interval 11.6 to 16.4
|
14.9 percentage of participants
Interval 12.4 to 17.4
|
SECONDARY outcome
Timeframe: 28 days after randomizationPopulation: We only report primary and secondary outcomes using available data without imputation. Because of missing data, the denominator may vary for selected outcomes as reported in the primary publication (PMID: 36688507).
Defined as a patient being alive and without assisted breathing, new renal replacement therapy, or vasopressors (excluding vasopressor use prior to 48 hours). Any day that a patient is alive and without organ support will represent days alive and free of organ support.
Outcome measures
| Measure |
Restrictive Fluids
n=778 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=778 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Organ Support Free Days
|
24 days
Interval 23.4 to 24.6
|
23.6 days
Interval 23.0 to 24.3
|
SECONDARY outcome
Timeframe: 28 days after randomizationVentilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.
Outcome measures
| Measure |
Restrictive Fluids
n=773 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=771 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Ventilator Free Days (VFD)
|
23.4 days
Interval 22.7 to 24.1
|
22.8 days
Interval 22.0 to 23.5
|
SECONDARY outcome
Timeframe: 28 days after randomizationThe number of calendar days between randomization and 28 days later that the patient is alive and without renal replacement therapy. Patients who died prior to day 28 are assigned zero renal replacement free days.
Outcome measures
| Measure |
Restrictive Fluids
n=737 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=738 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Renal Replacement Free Days
|
24.1 days
Interval 23.4 to 24.8
|
23.9 days
Interval 23.2 to 24.6
|
SECONDARY outcome
Timeframe: From study day 2 through day 28The number of calendar days between day 2 (eligibility starting 48 hours post randomization) and 26 days later that the patient is alive and without the use of vasopressor therapy. Patients who died prior to day 28 are assigned zero vasopressor free days.
Outcome measures
| Measure |
Restrictive Fluids
n=778 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=778 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Vasopressor Free Days
|
22 days
Interval 21.4 to 22.7
|
21.6 days
Interval 20.9 to 22.3
|
SECONDARY outcome
Timeframe: 28 days after randomizationDefined as the number of days spent alive out of the ICU to day 28.
Outcome measures
| Measure |
Restrictive Fluids
n=778 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=778 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
ICU Free Days
|
22.8 days
Interval 22.2 to 23.4
|
22.7 days
Interval 22.0 to 23.3
|
SECONDARY outcome
Timeframe: 28 days after randomizationDays alive post hospital discharge through day 28. Patients who die on or prior to day 28 are assigned zero hospital free days.
Outcome measures
| Measure |
Restrictive Fluids
n=778 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=778 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Hospital Free Days to Discharge Home
|
16.2 days
Interval 15.4 to 17.0
|
15.4 days
Interval 14.6 to 16.2
|
SECONDARY outcome
Timeframe: 28 days after randomizationPatients who receive invasive mechanical ventilation via endotracheal or tracheostomy tube, except those intubated solely for a procedure and extubated within 24 hours, through to study day 28 meet this endpoint. Non-invasive mechanical ventilation will not be included as an outcome. This is a binary outcome.
Outcome measures
| Measure |
Restrictive Fluids
n=701 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=687 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
New Intubation With Invasive Mechanical Ventilation by 28 Days
|
77 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 28 days after randomizationPatients receiving (new) renal replacement therapy through day 28. Patients with chronic renal replacement therapy initiated prior to the current sepsis illness were not eligible to meet this endpoint.
Outcome measures
| Measure |
Restrictive Fluids
n=738 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=738 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Initiation of Renal Replacement Therapy
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 72 hours after randomizationAssessment of renal function using the KDIGO staging system (using serum creatinine criteria only) between baseline and 72 hours post randomization to assess for de novo acute kidney injury (AKI) (e.g., meeting criteria for AKI by KDIGO criteria) or worsening AKI (e.g., increasing severity). Patients on chronic renal replacement therapy were not eligible for this endpoint determination. Scoring of 1-3 (using serum creatinine levels; a higher score indicates worsening kidney function): 1. creatinine level 1.5-1.9 times baseline OR \>/= 0.3 mg/dl (\>/= 25.5 umol/l) increase 2. creatinine level 2.0-2.9 times baseline 3. creatinine level 3.0 times baseline OR increase in serum creatinine to \>/=4.0mg/dl (\>/= 353 umol/l) OR initiation of renal replacement therapy
Outcome measures
| Measure |
Restrictive Fluids
n=585 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=604 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Kidney Disease: Change in Creatinine-based Global Outcomes (KIDGO) Score Between Baseline and 72 Hours
|
0.35 score on a scale
Interval 0.28 to 0.41
|
0.34 score on a scale
Interval 0.28 to 0.41
|
SECONDARY outcome
Timeframe: 72 hours after randomizationSOFA score was calculated at enrollment and at 72 hours using clinically available data.Total score: 0-4 points; 4 = worst outcome. Values not available at baseline were assumed normal. 72 hours assessment: Closest previously known value was carried forward for missing values. SOFA Scoring Breakout (lower scores mean a better outcome; clinically significant organ failure for CLOVERS was defined as a SOFA score 2 or more points higher than baseline): * Coagulation( Platelets, ×10³/µL): Score = 0: \>150; 1: \</= 150; 2: \</= 100; 3: \</= 50; 4: \</= 2 * Liver (Bilirubin, mg/dL): Score: 0: \<1.2; 1: 1.2-1.9; 2: 2.0-5.9; 3: 6.0-11.9; 4: \>11.9 * Cardiovascular(Hypotension): Score: 0: no hypotension; 1: Mean arterial pressure \<70 mmHg; 2: Dopamine\</=5 OR any dobutamine; 3: Dopanime \>5, epinephrine \</=0, or Norepi \</=0.1; 4: Dop \>15, epi \>0.1, or norepi \>0.1 * Renal (Creatinine, mg/dL or urine output, ml/d): Score: 0: \<1.2; 1: 1.2-1.9; 3: 2.0-3.4; 3: 3.5-4.9 or \<500; 4: \>4.9 or \<200
Outcome measures
| Measure |
Restrictive Fluids
n=619 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=634 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Change in SOFA (Sepsis Related Organ Failure Assessment) Score
|
-0.7 score on a scale
Interval -0.9 to -0.4
|
-0.8 score on a scale
Interval -1.0 to -0.5
|
SECONDARY outcome
Timeframe: 7 days after randomizationPresence and severity of ARDS is determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio and confirmation of ARDS through chest x-ray reviews.
Outcome measures
| Measure |
Restrictive Fluids
n=757 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=758 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Development of ARDS
|
19 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 28 days after randomizationThe occurrence of one or more episodes (sustained for more than 1 minute for SVT and AF, \> 15 seconds for VT) during through day 28 will be recorded.
Outcome measures
| Measure |
Restrictive Fluids
n=779 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=778 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
New Onset Atrial or Ventricular Arrhythmia
|
59 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: From randomization to and including day 90Subjects were contacted at day 90 to ascertain their survival status via telephone contact with the patient or family members or by a review of medical records and publicly available data sources.
Outcome measures
| Measure |
Restrictive Fluids
n=768 Participants
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=773 Participants
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Death From Any Cause at Any Location by Day 90
|
172 Participants
|
169 Participants
|
Adverse Events
Restrictive Fluids
Serious events: 18 serious events
Other events: 4 other events
Deaths: 172 deaths
Liberal Fluids
Serious events: 19 serious events
Other events: 14 other events
Deaths: 169 deaths
Serious adverse events
| Measure |
Restrictive Fluids
n=782 participants at risk
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=781 participants at risk
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.26%
2/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Polymorphic Vt
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
0.26%
2/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
General disorders
Death
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.51%
4/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Infections and infestations
Pneumonia
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Infections and infestations
Septic Shock
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Nervous system disorders
Cerebral Infarct
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Nervous system disorders
Seizure
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Renal and urinary disorders
Hematuria
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Renal and urinary disorders
Worsening Kidney Failure
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Vascular disorders
Hypotension
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Vascular disorders
Peripheral Ischemia
|
0.26%
2/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Pulmonary Edema
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.26%
2/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Flash Pulmonary Edema
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Fluid Overload
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.38%
3/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Myocardial Ischemia, Elevated Troponin
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
General disorders
Readmit
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.26%
2/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Skin and subcutaneous tissue disorders
Blisters
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
Other adverse events
| Measure |
Restrictive Fluids
n=782 participants at risk
The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.
Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
|
Liberal Fluids
n=781 participants at risk
The general approach is to use fluid boluses to treat hypotension.
Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. "Rescue vasopressors" may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Nervous system disorders
Seizure Vs Syncope Vasovagal
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Vascular disorders
Thrombosis Venous Deep
|
0.13%
1/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.00%
0/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.26%
2/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Fluid Overload
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.38%
3/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Pulmonary Edema
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Cardiac disorders
Transfusion Associated Circulatory Overload
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Renal and urinary disorders
Renal Calculus
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Hypoxia
|
0.00%
0/782 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
0.13%
1/781 • Assessment for adverse events was performed from trial enrollment through study day 6 (five days after completion of the study fluid protocol) or Hospital discharge, whichever occurs first. All-Cause All-Location Mortality was assessed up to 90 days from randomization. Please note that this outcome measure differs from the primary outcome of death before discharge home by day 90 and includes deaths after discharge home before day 90.
Events that were assessed to be serious or non-serious and that were considered to be related to study procedures or of uncertain relationship were captured. As noted previously, because of missing data the denominator may vary for selected outcomes. The number of patients at risk for adverse events is all patients randomized (no missing data). All deaths due to any cause to day 90 are reported.
|
Additional Information
PETAL Clinical Coordinating Center PI
Massachusetts General Hospital
Phone: 617-872-2882
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place