Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock

Not Applicable

Completed

• Conditions: Hypotension; Septic Shock; Fluid Therapy
• Interventions: Other: Fluid minimization protocol; Device: Ultrasound

• Registration Number: NCT02473718
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of the study is to determine if a protocol that assesses patients' daily fluid intake and output can decrease the overall amount of fluid patients receive during the first five days in the ICU. The study will also determine if decreasing overall fluids can decrease adverse events associated with mechanical ventilation, such as ventilator-associated pneumonias.

The protocol will include daily ultrasounds and blood draws to evaluate fluid balance. Ultrasound will be used to measure changes in the diameter of the inferior vena cava with respiration.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-16
• Results First Submitted: 2018-01-31
• Results First Submitted QC: 2018-02-27
• Results First Posted: 2018-03-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Adult patient with septic shock as the primary cause of hypotension
2. Requiring vasopressors for 12 hours after adequate fluid resuscitation and at the time of enrollment

Read More

Exclusion Criteria

1. Patients with a history of end-stage renal disease requiring outpatient dialysis
2. Patients whose goals of care are consistent with comfort measures only
3. Pregnant patients

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid minimization group	Fluid minimization protocol	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. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. A fluid challenge in the form of a leg raise or infusion of 250 mL of crystalloid over 5 minutes will then be performed and the parameters repeated. The patient will be judged to be fluid responsive or nonresponsive based on the changes in the parameters. Fluid nonresponsive patients will receive the intervention of the fluid minimization protocol by concentrating continuous infusions, discontinuing maintenance fluids, and minimizing carrier fluids. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
Fluid minimization group	Ultrasound	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. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. A fluid challenge in the form of a leg raise or infusion of 250 mL of crystalloid over 5 minutes will then be performed and the parameters repeated. The patient will be judged to be fluid responsive or nonresponsive based on the changes in the parameters. Fluid nonresponsive patients will receive the intervention of the fluid minimization protocol by concentrating continuous infusions, discontinuing maintenance fluids, and minimizing carrier fluids. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.

Primary Outcome Measures

Name	Time	Method
Cumulative Fluid Administered	Day 5	Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5
Net Fluid Balance	Day 5	Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5

Secondary Outcome Measures

Name	Time	Method
Ventilator Days	Hospital stay, median of 16 days	Number of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation
Rate of Renal Replacement Therapy	ICU stay, median of 10 days	Percentage of patients requiring renal replacement therapy
Mortality	ICU stay, median of 10 days	Percentage of patients who died during their ICU stay