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

Not Applicable
Completed
Conditions
Hypotension
Septic Shock
Fluid Therapy
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

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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Cumulative Fluid AdministeredDay 5

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

Net Fluid BalanceDay 5

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

Secondary Outcome Measures
NameTimeMethod
Ventilator DaysHospital stay, median of 16 days

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

Rate of Renal Replacement TherapyICU stay, median of 10 days

Percentage of patients requiring renal replacement therapy

MortalityICU stay, median of 10 days

Percentage of patients who died during their ICU stay

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