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REstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH): study protocol for a pilot randomised
Stephen P J Macdonald1,2,3, David McD Taylor4,5, Gerben Keijzers6,7,8
1Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, WA, Australia. stephen.macdonald@uwa.edu.au.
Trials
|August 31, 2017
Summary
This study investigates fluid resuscitation for sepsis-induced hypotension. It compares standard care with restricted fluid administration to determine optimal treatment strategies for septic shock patients.
Area of Science:
- Critical Care Medicine
- Emergency Medicine
- Clinical Trials
Background:
- Current sepsis guidelines recommend a 30 ml/kg intravenous fluid bolus for hypotension, but clinical trial evidence is lacking.
- Observational data suggest potential harm from excessive fluid administration in sepsis.
- There is equipoise regarding liberal versus restricted fluid resuscitation for sepsis-related hypotension.
Purpose of the Study:
- To assess the feasibility of a large-scale randomized trial comparing restricted versus standard fluid resuscitation in sepsis-associated hypotension.
- To evaluate the impact of different fluid resuscitation strategies on key clinical outcomes and biomarkers.
Main Methods:
- The REstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH) trial is a multicenter, open-label, randomized feasibility trial.
- Patients with suspected sepsis and hypotension after an initial fluid bolus were randomized to standard care (additional bolus) or restricted fluid (maintenance fluids and early vasopressors).
- Primary outcome was total fluid volume in the first 6 hours; secondary outcomes included fluid volume at 24 hours, organ support-free days, and 90-day mortality.
Main Results:
- Feasibility of conducting a large international trial was established.
- The study design allows for assessment of clinical outcomes and provides mechanistic insights through biomarker analysis.
- Differences in fluid volumes and biomarker profiles between groups were analyzed.
Conclusions:
- This trial provides a foundation for a larger international study on fluid resuscitation in septic shock.
- The findings will inform evidence-based guidelines for fluid management in sepsis.
- Understanding the effects of fluid volume on systemic inflammation and vascular endothelium is crucial.
