At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Optimization Phase of Fluid Therapy in the Critically Ill (the RESPONSE Trial)
In Brief
A clinical study evaluating follow-up without intervention and fluid bolus for Critically Ill and 3 related conditions. Completed, enrolled 130 participants across 2 sites.
Detailed Summary
Background: After hypotension, oliguria (urine output less than 0.5 mL/kg/h) was the most common trigger to administer fluid bolus in a multinational practice survey in intensive care. The effect of fluid bolus on cardiovascular variables can be very short-lived among patients in shock suggesting that fluid boluses in the optimization phase are unlikely to improve patient-centered outcomes. Moreover, a growing body of evidence suggests a poor renal response to fluid bolus. Objective: To investigate, whether fluid bolus - as a standard of care - improves urine output in oliguric patients compared to a non-interventional follow-up approach without fluid bolus. Design: Investigator-initiated, open, randomized, controlled study Interventions: 1. Intervention group - follow-up without intervention 2. Control group - fluid bolus (500mL of balanced crystalloid over 30 minutes) Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and sepsis Trial size: 130 patients randomized in 2 ICUs