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

Washington University School of Medicine82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Septic Shock Fluid Therapy Hypotension

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

Cumulative Fluid Administered

Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3

Time frame: Day 3

Cumulative Fluid Administered

Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5

Time frame: Day 5

Net Fluid Balance

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

Time frame: Day 3

Net Fluid Balance

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

Time frame: Day 5

Secondary Outcomes

Ventilator Days

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

Time frame: Hospital stay, median of 16 days

Rate of Renal Replacement Therapy

Percentage of patients requiring renal replacement therapy

Time frame: ICU stay, median of 10 days

Mortality

Percentage of patients who died during their hospitalization

Time frame: Hospital stay, median of 16 days

Mortality

Percentage of patients who died during their ICU stay

Time frame: ICU stay, median of 10 days