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

Study Overview
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Brief Summary
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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.

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

Conditions
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Septic Shock, Fluid Therapy, Hypotension

Intervention / Treatment
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* Other: Fluid minimization protocol
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient with septic shock as the primary cause of hypotension Requiring vasopressors for 12 hours after adequate fluid resuscitation and at the time of enrollment Exclusion Criteria: Patients with a history of end-stage renal disease requiring outpatient dialysis Patients whose goals of care are consistent with comfort measures only Pregnant patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluid minimization group<br>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. | Other: Fluid minimization protocol<br>* 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 in patients demonstrating fluid non-responsiveness.<br>Device: Ultrasound<br> <br> |
| No Intervention: Usual care group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Fluid Administered | Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3 | Day 3 | 
| Cumulative Fluid Administered | Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5 | Day 5 | 
| Net Fluid Balance | Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3 | Day 3 | 
| Net Fluid Balance | Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5 | Day 5 | 

Secondary Outcome Measures

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