Trial Outcomes & Findings for Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma (NCT NCT01411852)
NCT ID: NCT01411852
Last Updated: 2015-01-13
Results Overview
The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first
Results posted on
2015-01-13
Participant Flow
Patients were enrolled and randomized in the out-of-hospital setting. Nineteen Emergency Medical Service (EMS) systems and 10 hospital in 6 regions of the Resuscitation Outcomes Consortium (ROC) participated.
Participant milestones
| Measure |
0.9% Sodium Chloride 2000 mL Bolus
0.9% Sodium Chloride 2000 mL bolus - An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.
0.9% Sodium Chloride 2000 mL bolus: The systolic blood pressure (SBP) is the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. Once the total fluid reaches 2 liters and the SBP exceeds 110 mmHg, the fluid will be stopped and restarted as necessary to maintain a goal SBP of 110 mmHg.
|
0.9% Sodium Chloride 250 mL Bolus
0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.
0.9% Sodium Chloride 250 mL bolus: Either systolic blood pressure (SBP) or radial pulse is the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients receive 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS is given only to keep the vein open. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.
|
|---|---|---|
|
Prehospital Intervention Phase
STARTED
|
95
|
96
|
|
Prehospital Intervention Phase
COMPLETED
|
83
|
89
|
|
Prehospital Intervention Phase
NOT COMPLETED
|
12
|
7
|
|
Hospital Intervention Phase
STARTED
|
83
|
89
|
|
Hospital Intervention Phase
COMPLETED
|
59
|
71
|
|
Hospital Intervention Phase
NOT COMPLETED
|
24
|
18
|
Reasons for withdrawal
| Measure |
0.9% Sodium Chloride 2000 mL Bolus
0.9% Sodium Chloride 2000 mL bolus - An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.
0.9% Sodium Chloride 2000 mL bolus: The systolic blood pressure (SBP) is the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. Once the total fluid reaches 2 liters and the SBP exceeds 110 mmHg, the fluid will be stopped and restarted as necessary to maintain a goal SBP of 110 mmHg.
|
0.9% Sodium Chloride 250 mL Bolus
0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.
0.9% Sodium Chloride 250 mL bolus: Either systolic blood pressure (SBP) or radial pulse is the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients receive 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS is given only to keep the vein open. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.
|
|---|---|---|
|
Prehospital Intervention Phase
No qualifying SBP
|
5
|
4
|
|
Prehospital Intervention Phase
Cardiopulmonary resuscitation (CPR)
|
2
|
2
|
|
Prehospital Intervention Phase
Found to be under age
|
0
|
1
|
|
Prehospital Intervention Phase
Severe head injury with GCS≤8
|
5
|
0
|
|
Hospital Intervention Phase
Severe head injury
|
5
|
4
|
|
Hospital Intervention Phase
No qualifying SBP
|
5
|
1
|
|
Hospital Intervention Phase
Miscommunication error
|
1
|
2
|
|
Hospital Intervention Phase
CPR administered
|
3
|
1
|
|
Hospital Intervention Phase
Misunderstanding of protocol
|
4
|
1
|
|
Hospital Intervention Phase
Diagnosis of sepsis
|
0
|
2
|
|
Hospital Intervention Phase
Diagnosis of dehydration
|
0
|
1
|
|
Hospital Intervention Phase
Physician/hospital staff noncompliance
|
0
|
4
|
|
Hospital Intervention Phase
Other ineligible
|
2
|
2
|
|
Hospital Intervention Phase
Spinal cord injury
|
2
|
0
|
|
Hospital Intervention Phase
Withdrawal by Subject
|
1
|
0
|
|
Hospital Intervention Phase
Vascular access failed
|
1
|
0
|
Baseline Characteristics
Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
Baseline characteristics by cohort
| Measure |
Standard Resuscitation (SR)
n=95 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=96 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 19.2 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 20.2 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 19.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Penetrating trauma
Penetrating primary mechanism of injury
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Penetrating trauma
Blunt force primary mechanism of injury
|
62 participants
n=5 Participants
|
63 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Penetrating trauma
Neither penetrating or blunt force
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Injury Severity Score (ISS)
|
9 units on a scale
n=5 Participants
|
9.5 units on a scale
n=7 Participants
|
9 units on a scale
n=5 Participants
|
|
Injury Severity Score (ISS): Number of Severely Injured
Severely injured with ISS > 15
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Injury Severity Score (ISS): Number of Severely Injured
Mildly injured with ISS ≤ 15
|
62 participants
n=5 Participants
|
63 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Injury Severity Score (ISS): Number of Severely Injured
Died in field with no AIS available
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Glasgow Coma Score (GCS) prior to enrollment
|
12.4 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
13 units on a scale
STANDARD_DEVIATION 3.6 • n=7 Participants
|
12.7 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Advanced airway
Number of patients with advanced airway inserted
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Advanced airway
Number of patients with no advanced airway
|
83 participants
n=5 Participants
|
89 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Revised Trauma Score (RTS)
|
6.4 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Initial SBP
|
84 mmHg
n=5 Participants
|
81.5 mmHg
n=7 Participants
|
84 mmHg
n=5 Participants
|
|
Qualifying SBP
|
82 mmHg
n=5 Participants
|
78 mmHg
n=7 Participants
|
80 mmHg
n=5 Participants
|
|
Initial heart rate (HR)
|
91.9 number of heart beats per minute
STANDARD_DEVIATION 24.2 • n=5 Participants
|
94.7 number of heart beats per minute
STANDARD_DEVIATION 22.9 • n=7 Participants
|
93.3 number of heart beats per minute
STANDARD_DEVIATION 23.5 • n=5 Participants
|
|
Air transport
Number transported by air
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Air transport
Number transported by ground
|
88 participants
n=5 Participants
|
91 participants
n=7 Participants
|
179 participants
n=5 Participants
|
|
Air transport
Number died prior to transport
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Time from dispatch call to first intravenous/intraosseous access (IV/IO)
|
22.1 minutes
STANDARD_DEVIATION 9.9 • n=5 Participants
|
21 minutes
STANDARD_DEVIATION 8.7 • n=7 Participants
|
21.5 minutes
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Total out-of-hospital time
|
41 minutes
STANDARD_DEVIATION 13.8 • n=5 Participants
|
42.7 minutes
STANDARD_DEVIATION 16.5 • n=7 Participants
|
41.9 minutes
STANDARD_DEVIATION 15.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs firstPopulation: Patients with traumatic shock due to blunt or penetrating mechanisms
The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=95 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=96 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
n=191 Participants
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility)
|
2.04 liters
Interval 1.76 to 2.32
|
1.04 liters
Interval 0.75 to 1.34
|
1 liters
Interval 0.6 to 1.4
|
PRIMARY outcome
Timeframe: From time of hospital arrival through the first 24 hoursPopulation: All patients except for one who was enrolled while in police custody
The 24 hour mortality endpoint for the total number of patients each arm
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=95 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=96 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
24 Hour Mortality
Died within first 24 hours after hospital arrival
|
14 participants
|
5 participants
|
—
|
|
24 Hour Mortality
Alive at 24 hours after hospital arrival
|
81 participants
|
91 participants
|
—
|
SECONDARY outcome
Timeframe: From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrivalPopulation: All patients enrolled in the study.
Eligibility criteria: Inclusion Criteria Included will be those with: 1. Blunt or penetrating injury 2. Age ≥15yrs or weight ≥50kg if age is unknown 3. Prehospital SBP ≤ 90 mmHg 5.3 Exclusion Criteria Excluded will be those with: 1. Ground level falls 2. Evidence of severe blunt or penetrating head injury with a Glasgow Coma Score (GCS) ≤ 8 3. Bilateral paralysis secondary to suspected spinal cord injury 4. Fluid greater than 250 ml was given prior to randomization 5. Cardiopulmonary resuscitation (CPR) by Emergency Medical Services (EMS) prior to randomization 6. Known prisoners 7. Known or suspected pregnancy 8. Drowning or asphyxia due to hanging 9. Burns Total Body Surface Area (TBSA) \> 20% 10. Time of call received at dispatch to study intervention \> 4 hours
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=95 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=97 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Number of Ineligible Patients Enrolled at the Time of Randomization
|
24 participants
|
9 participants
|
—
|
SECONDARY outcome
Timeframe: From ED arrival through the first 24 hoursPopulation: All patients except one who was enrolled while in police custody
Total volume of fluid administered during the first 24 hours inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=95 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=96 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Total Fluid Requirement During First 24 Hours
|
4.43 Liters
Standard Deviation 4.02
|
5.61 Liters
Standard Deviation 6.71
|
—
|
SECONDARY outcome
Timeframe: From ED arrival through the first 24 hoursPopulation: All patients except one who was enrolled while in police custody
Total amount of blood products required: packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets (plts), cryoprecipitate (cryo)
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=95 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=96 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Total Blood Product Requirements in First 24 Hours
|
0.84 Liters
Standard Deviation 2.24
|
1.61 Liters
Standard Deviation 3.53
|
—
|
SECONDARY outcome
Timeframe: From final Emergency Department arrival time through first 24 hoursPopulation: Patient with the first base deficit recorded in the first 24 hours of the ED arrival
The first base deficit value reported from arterial blood lab work drawn after arrival in the final Emergency Department. This measure reflects the acid-base balance in the arterial blood. A negative number indicates that the blood is more acid that normal.
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=55 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=58 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Base Deficit on Admission to the Emergency Department (ED)
|
6.4 mmol/Liter
Standard Deviation 5.2
|
6.2 mmol/Liter
Standard Deviation 5.7
|
—
|
SECONDARY outcome
Timeframe: From final Emergency Department arrival time through first 24 hoursPopulation: All patients with a first hemoglobin measured within the first 24 hours of ED arrival
The first hemoglobin value reported from blood drawn in the final Emergency Department
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=86 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=89 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Hemoglobin on Admission to the Emergency Department
|
12.6 grams/deciliter
Standard Deviation 2.1
|
12.3 grams/deciliter
Standard Deviation 2.3
|
—
|
SECONDARY outcome
Timeframe: From final Emergency Department arrival time through first 24 hoursPopulation: All patients with the first platelet value measured within the first 24 hours of ED arrival
First platelet value from blood drawn in the the first 24 hours after arrival
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=83 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=86 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Platelet Value on Admission
|
219.5 10^9 Platelets/Liters
Standard Deviation 61.8
|
239.9 10^9 Platelets/Liters
Standard Deviation 82.4
|
—
|
SECONDARY outcome
Timeframe: From final Emergency Department arrival time through first 24 hoursPopulation: Patients who had a first INR value measured within the first 24 hours of ED arrival
The first International normalized ratio (INR) value reported from blood drawn within the first 24 hours from arrival
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=74 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=74 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
International Normalized Ratio (INR) on Admission to the Emergency Department
|
1.18 ratio
Standard Deviation 0.26
|
1.16 ratio
Standard Deviation 0.25
|
—
|
SECONDARY outcome
Timeframe: From ED arrival through the first 2 hoursPopulation: All patients except for 1 patient who was enrolled while in police custody
Hemorrhage control procedures include blood vessel ligated or embolized, organ packed or removed, laparotomy or thoracotomy
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=95 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=96 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Hemorrhage Control Procedure Within 2 Hours of ED Arrival
|
19 participants
|
29 participants
|
—
|
SECONDARY outcome
Timeframe: From ED arrival through Day 28Population: Patients with at least a 2 day ICU stay
Increased plasma creatinine \> 1.5 x reference measure (ED admission). Urine criteria is based on 6-hour periods for this level of the RIFLE and cannot be assessed since study data are collected for 24-hour periods. This row includes patients who met the "Injury" and "Failure" criteria as well. Only measured for patients with at least 2 days of ICU stay assessed.
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=24 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=35 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Acute Renal Failure Classification Score of "Risk" Without Glomerular Filtration Rate (GFR)
|
3 participants
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: From ED arrival through Day 28Population: Patients with at least at 2 day stay in the ICU
Increased plasma creatinine \> 2 x reference measure (ED admission) or urine output \< 0.5 mL/kg/h x 24h. The RIFLE urine criterion for this level actually specifies a 12 hour period of assessment but study data are collected for 24-hr periods. This row includes patients who met the "Failure" criteria as well. Only measured for patients with at least 2 days of ICU stay assessed.
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=24 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=35 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Acute Renal Failure Classification Score of "Injury" Without Glomerular Filtration Rate (GFR)
|
3 participants
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: From ED arrival through the first 24 hoursPopulation: Patients with at least at 2 day stay in the ICU
Increased plasma creatinine \> 3 x reference measure (ED admission) or acute plasma creatinine = 350 umol/L or acute rise = 44 umol/L or urine output \< 0.3 mL/k/h x 24h. Only measured for patients with at least 2 days of ICU stay assessed.
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=24 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=35 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Acute Renal Failure Classification Score of "Failure" Without Glomerular Filtration Rate (GFR)
|
1 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: From day of the 911 call through Day 28Population: Patients with known discharge status.
The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which the patient did not require mechanical ventilation. Deaths are assigned the worst score (0).
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=91 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=95 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Ventilator Free Days Through Day 28
|
23.6 Ventilator-free days
Standard Deviation 10.7
|
24.5 Ventilator-free days
Standard Deviation 9.5
|
—
|
SECONDARY outcome
Timeframe: From day of the 911 call through Day 28Population: Patients with known discharge status
The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which the patient is alive and not being cared for in the intensive care unit
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=91 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=95 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Days Alive Out of the Intensive Care Unit (ICU) Through Day 28
|
23.0 ICU-free days
Standard Deviation 10.7
|
23.6 ICU-free days
Standard Deviation 9.8
|
—
|
SECONDARY outcome
Timeframe: From day of the 911 call through Day 28Population: Patients with known discharge status
The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which the patient is alive and not being cared for in the hospital
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=91 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=95 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Days Alive Out of the Hospital Through Day 28
|
18.6 Days alive out of hospital thru day 28
Standard Deviation 10.3
|
18.5 Days alive out of hospital thru day 28
Standard Deviation 10.5
|
—
|
SECONDARY outcome
Timeframe: From time of hospital arrival through first 24 hoursPopulation: Analyzed patients had traumatic shock due to blunt traumatic mechanisms. One patient randomized to the controlled resuscitation group was not analyzed because neither blunt force nor penetrating injury had occurred. It was determined that the source of bleeding was from a gastrointestinal lesion.
The 24 hour mortality endpoint for the total number of patients injured by blunt mechanisms in each arm.
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=62 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=63 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Blunt Trauma 24 Hour Mortality
Died within first 24 hours after hospital arrival
|
11 participants
|
2 participants
|
—
|
|
Blunt Trauma 24 Hour Mortality
Alive at 24 hours after hospital arrival
|
51 participants
|
61 participants
|
—
|
SECONDARY outcome
Timeframe: From time of hospital arrival through first 24 hoursPopulation: Patients with traumatic shock due to penetrating traumatic mechanisms
The 24 hour mortality endpoint for the total number of patients injured by penetrating mechanisms in each arm.
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=33 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=32 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
Penetrating Trauma 24 Hour Mortality
Alive at 24 hours after hospital arrival
|
30 participants
|
29 participants
|
—
|
|
Penetrating Trauma 24 Hour Mortality
Died within first 24 hours after hospital arrival
|
3 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: From day of the 911 call through hospital dischargePopulation: All enrolled patients
Number of patients who died prior to discharge.
Outcome measures
| Measure |
Standard Resuscitation (SR)
n=91 Participants
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=95 Participants
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
|
ECV Difference [Standard - Controlled]
ECV treatment difference between SR and CR
|
|---|---|---|---|
|
In-hospital Mortality
|
15 participants
|
8 participants
|
—
|
Adverse Events
Standard Resuscitation (SR)
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Controlled Resuscitation (CR)
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Resuscitation (SR)
n=95 participants at risk
Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
|
Controlled Resuscitation (CR)
n=96 participants at risk
Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
The total number of patients at risk is one less than the total number of patients enrolled. Regulatory restrictions for prisoners required that no data collection, including severe adverse events, be performed for the patient who was determined to have been in police custody at the time of enrollment.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.1%
2/95 • Number of events 2 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
6.2%
6/96 • Number of events 6 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
3/95 • Number of events 3 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
3.1%
3/96 • Number of events 3 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Infections and infestations
Wound infection
|
0.00%
0/95 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
5.2%
5/96 • Number of events 5 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Infections and infestations
Sepsis
|
1.1%
1/95 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
1.0%
1/96 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Infections and infestations
Bloodstream infection
|
0.00%
0/95 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
1.0%
1/96 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Infections and infestations
Intra-abdominal abscess
|
0.00%
0/95 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
1.0%
1/96 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Renal and urinary disorders
Renal impairment
|
3.2%
3/95 • Number of events 3 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
7.3%
7/96 • Number of events 7 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/95 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
1.0%
1/96 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Vascular disorders
Deep vein thrombosis (DVT)
|
1.1%
1/95 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
2.1%
2/96 • Number of events 2 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Vascular disorders
Pulmonary embolus
|
0.00%
0/95 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
1.0%
1/96 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
0.00%
0/95 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
1.0%
1/96 • Number of events 1 • Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
One CR patient enrolled as prisoner, which prohibited study data collection.
|
Other adverse events
Adverse event data not reported
Additional Information
Susanne May, PhD, Principal Investigator
Resuscitation Outcomes Consortium
Phone: 206-685-1302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Research activities of the Resuscitation Outcomes Consortium (ROC) are intended to contribute applicable knowledge to the field of Resuscitative Medicine. Definitive contributions are made through publications in peer-reviewed literature. No participating institution may present or publish individual findings from work performed on study protocols without approval of the Publications Subcommittee (PS).
- Publication restrictions are in place
Restriction type: OTHER