N/A
N=82
Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock
Septic Shock · Fluid Therapy · Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT02473718 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Cumulative Fluid Administered — 4417; 4110 mL of study fluid
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluid minimization protocol (Other); Ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Fluid Administered |
6244; 8690 | — |
| PRIMARY Cumulative Fluid Administered |
6244; 8690 | — |
| PRIMARY Net Fluid Balance |
2641; 3616 | — |
| PRIMARY Net Fluid Balance |
2641; 3616 | — |
| SECONDARY Ventilator Days |
8; 5 | — |
| SECONDARY Rate of Renal Replacement Therapy |
17; 16 | — |
| SECONDARY Mortality |
23; 20 | — |
| SECONDARY Mortality |
23; 20 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02473718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.