Trial Outcomes & Findings for Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock (NCT NCT02473718)
NCT ID: NCT02473718
Last Updated: 2024-07-24
Results Overview
Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3
COMPLETED
NA
82 participants
Day 3
2024-07-24
Participant Flow
Participant milestones
| Measure |
Fluid Minimization Group
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fluid Minimization Group
n=41 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=41 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=41 Participants
|
31 Participants
n=41 Participants
|
62 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=41 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=82 Participants
|
|
Age, Continuous
|
58 years
n=41 Participants
|
60 years
n=41 Participants
|
58 years
n=82 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=41 Participants
|
20 Participants
n=41 Participants
|
41 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=41 Participants
|
21 Participants
n=41 Participants
|
41 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
41 Participants
n=41 Participants
|
41 Participants
n=41 Participants
|
82 Participants
n=82 Participants
|
|
APACHE II score
|
25 units on a scale
n=41 Participants
|
26 units on a scale
n=41 Participants
|
25 units on a scale
n=82 Participants
|
|
SOFA score
|
13 units on a scale
n=41 Participants
|
12 units on a scale
n=41 Participants
|
13 units on a scale
n=82 Participants
|
|
BMI
|
32.62 kg/m^2
n=41 Participants
|
31.13 kg/m^2
n=41 Participants
|
32.33 kg/m^2
n=82 Participants
|
|
Intubation status
|
28 Participants
n=41 Participants
|
31 Participants
n=41 Participants
|
59 Participants
n=82 Participants
|
|
Presence of ARDS
|
26 Participants
n=41 Participants
|
25 Participants
n=41 Participants
|
51 Participants
n=82 Participants
|
|
Presence of COPD
|
5 Participants
n=41 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=82 Participants
|
|
Presence of hypertension
|
14 Participants
n=41 Participants
|
19 Participants
n=41 Participants
|
33 Participants
n=82 Participants
|
|
Presence of hyperlipidemia
|
10 Participants
n=41 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=82 Participants
|
|
Presence of diabetes mellitus
|
12 Participants
n=41 Participants
|
10 Participants
n=41 Participants
|
22 Participants
n=82 Participants
|
|
Presence of systolic heart failure
|
4 Participants
n=41 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=82 Participants
|
|
Presence of diastolic heart failure
|
4 Participants
n=41 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=82 Participants
|
|
Presence of chronic kidney disease
|
6 Participants
n=41 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=82 Participants
|
|
Presence of active malignancy
|
16 Participants
n=41 Participants
|
10 Participants
n=41 Participants
|
26 Participants
n=82 Participants
|
|
Presence of end-stage liver disease
|
13 Participants
n=41 Participants
|
7 Participants
n=41 Participants
|
20 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Day 3Population: Five patients in the fluid minimization group and two patients in the usual care group died prior to the first time point analysis at day three. One patient in the usual care group was transferred out of the ICU prior to the first time point analysis at day 3.
Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3
Outcome measures
| Measure |
Fluid Minimization Group
n=36 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=38 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Cumulative Fluid Administered
|
4417 mL of study fluid
Interval 3139.0 to 6528.0
|
4110 mL of study fluid
Interval 2702.0 to 10004.0
|
PRIMARY outcome
Timeframe: Day 5Population: Five patients in the fluid minimization group and four patients in the usual care group died prior to analysis at day 5. Five patients in the fluid minimization group and six patients in the usual care group were transferred out of the ICU prior to analysis at day 5.
Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5
Outcome measures
| Measure |
Fluid Minimization Group
n=31 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=31 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Cumulative Fluid Administered
|
6244 mL of study fluid
Interval 5106.0 to 8497.0
|
8690 mL of study fluid
Interval 4211.0 to 13197.0
|
PRIMARY outcome
Timeframe: Day 3Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3
Outcome measures
| Measure |
Fluid Minimization Group
n=36 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=38 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Net Fluid Balance
|
1952 mL
Interval 48.0 to 5003.0
|
3124 mL
Interval 767.0 to 10103.0
|
PRIMARY outcome
Timeframe: Day 5Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5
Outcome measures
| Measure |
Fluid Minimization Group
n=31 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=31 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Net Fluid Balance
|
2641 mL
Interval -1837.0 to 5075.0
|
3616 mL
Interval -1513.0 to 9746.0
|
SECONDARY outcome
Timeframe: Hospital stay, median of 16 daysNumber of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation
Outcome measures
| Measure |
Fluid Minimization Group
n=41 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=41 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Ventilator Days
|
8 days
Interval 3.25 to 15.25
|
5 days
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: ICU stay, median of 10 daysPercentage of patients requiring renal replacement therapy
Outcome measures
| Measure |
Fluid Minimization Group
n=41 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=41 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Rate of Renal Replacement Therapy
|
17 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Hospital stay, median of 16 daysPercentage of patients who died during their hospitalization
Outcome measures
| Measure |
Fluid Minimization Group
n=41 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=41 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Mortality
|
23 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: ICU stay, median of 10 daysPercentage of patients who died during their ICU stay
Outcome measures
| Measure |
Fluid Minimization Group
n=41 Participants
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Intubated patients will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. Fluid challenge as a leg raise or infusion of 250 mL of crystalloid over 5 minutes will be performed and parameters repeated. Fluid responsiveness based on the changes in the parameters. Fluid nonresponsive patients will undergo the fluid minimization protocol.
Fluid minimization protocol: Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
|
Usual Care Group
n=41 Participants
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
|
|---|---|---|
|
Mortality
|
23 Participants
|
20 Participants
|
Adverse Events
Fluid Minimization Group
Usual Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Catherine Chen
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place