Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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)
Brief 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:
Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and sepsis
Trial size: 120 patients randomized in 4 ICUs