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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

Day 3

Results posted on

2024-07-24

Participant Flow

Participant milestones

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

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 3

Population: 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

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 5

Population: 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

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 3

Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3

Outcome measures

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 5

Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5

Outcome measures

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 days

Number of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation

Outcome measures

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 days

Percentage of patients requiring renal replacement therapy

Outcome measures

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 days

Percentage of patients who died during their hospitalization

Outcome measures

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 days

Percentage of patients who died during their ICU stay

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 23 deaths

Usual Care Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 20 deaths

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

Phone: 214-648-9095

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place