Noninterventional follow-up vs fluid bolus in RESPONSE to oliguria-The RESPONSE trial protocol and statistical analysis plan

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Inkinen , N , Selander , T , Pettila , V , Valkonen , M , Bäcklund , M , Wennervirta , J , Pulkkinen , A , Hästbacka , J & Vaara , S T 2020 , ' Noninterventional follow-up vs fluid bolus in RESPONSE to oliguria-The RESPONSE trial protocol and statistical analysis plan ' , Acta Anaesthesiologica Scandinavica , vol. 64 , no. 8 , pp. 1210-1217 . https://doi.org/10.1111/aas.13599

Title: Noninterventional follow-up vs fluid bolus in RESPONSE to oliguria-The RESPONSE trial protocol and statistical analysis plan
Author: Inkinen, Nina; Selander, Tuomas; Pettila, Ville; Valkonen, Miia; Bäcklund, Minna; Wennervirta, Johanna; Pulkkinen, Anni; Hästbacka, Johanna; Vaara, Suvi T.
Other contributor: University of Helsinki, Anestesiologian yksikkö
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, Clinicum
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine





Date: 2020-09
Language: eng
Number of pages: 8
Belongs to series: Acta Anaesthesiologica Scandinavica
ISSN: 0001-5172
DOI: https://doi.org/10.1111/aas.13599
URI: http://hdl.handle.net/10138/318597
Abstract: Background Oliguria 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. Methods Our 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. Conclusions Oliguria 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 registration clinical.trials.gov, NCT02860572.
Subject: acute kidney injury
critically ill
fluid bolus
oliguria
ACUTE KIDNEY INJURY
CRITICALLY-ILL PATIENTS
SEVERE SEPSIS
THERAPY
SHOCK
FUROSEMIDE
PREDICT
FLOW
3126 Surgery, anesthesiology, intensive care, radiology
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