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Acta Anaesthesiol Scand · Sep 2020
Randomized Controlled Trial Multicenter Study Comparative StudyNon-interventional follow-up versus fluid bolus in RESPONSE to oliguria- The RESPONSE trial protocol and statistical analysis plan.
- Nina Inkinen, Tuomas Selander, Ville Pettilä, Miia Valkonen, Minna Bäcklund, Johanna Wennervirta, Anni Pulkkinen, Johanna Hästbacka, and Suvi T Vaara.
- Department of Anesthesia and Intensive Care, Central Finland Central Hospital, Central Finland Health Care District, Jyväskylä, Finland.
- Acta Anaesthesiol Scand. 2020 Sep 1; 64 (8): 1210-1217.
BackgroundOliguria is a frequent trigger for administering a fluid bolus, but the effect of fluid bolus in improving urine output is inadequately demonstrated. Here, we summarize the protocol and detailed statistical analysis plan of the randomized, controlled RESPONSE trial comparing follow-up as the experimental group and a 500 mL crystalloid fluid bolus as the control group for oliguria in critically ill oliguric patients.MethodsOur trial is an investigator-initiated, randomized, controlled, pilot trial conducted in three ICUs in two centers. We aim to randomize 1:1 altogether 130 hemodynamically stable oliguric patients either to a 2-hour follow-up without interventions or to receive a crystalloid bolus of 500 mL over 30 minutes. The primary outcome is the change in individual urine output during the 2-hour period compared to 2 hours preceding randomization. Doubling of the urine output is considered clinically significant. Additionally, we record the duration of oliguria, physiological and biochemical variables, adverse events, and the incidences of acute kidney injury and renal replacement therapy.ConclusionsOliguria is a frequent trigger for potentially harmful fluid loading. Therefore, the RESPONSE trial will give information of the potential effect of fluid bolus on oliguria in critically ill patients.Trial Registrationclinical.trials.gov, NCT02860572.© 2020 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
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