1. Noninterventional follow‐up vs fluid bolus in RESPONSE to oliguria—The RESPONSE trial protocol and statistical analysis plan
- Author
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Suvi T. Vaara, Anni Pulkkinen, Miia Valkonen, Ville Pettilä, Minna Bäcklund, Johanna Wennervirta, Nina Inkinen, Tuomas Selander, Johanna Hästbacka, Anestesiologian yksikkö, HUS Perioperative, Intensive Care and Pain Medicine, University of Helsinki, Helsinki University Hospital Area, Department of Diagnostics and Therapeutics, and Clinicum
- Subjects
Time Factors ,medicine.medical_treatment ,FLOW ,critically ill ,fluid bolus ,Pilot Projects ,urologic and male genital diseases ,THERAPY ,PREDICT ,0302 clinical medicine ,Statistical Analysis Plan ,Bolus (medicine) ,Clinical Protocols ,Oliguria ,Medicine ,030212 general & internal medicine ,Finland ,Acute kidney injury ,Furosemide ,General Medicine ,3. Good health ,Treatment Outcome ,acute kidney injury ,Research Design ,Anesthesia ,SHOCK ,Special Articles ,Original Article ,oliguria ,medicine.symptom ,CRITICALLY-ILL PATIENTS ,medicine.drug ,Adult ,Randomization ,Critical Care ,Critical Illness ,FUROSEMIDE ,03 medical and health sciences ,Young Adult ,Humans ,Renal replacement therapy ,Adverse effect ,business.industry ,030208 emergency & critical care medicine ,Crystalloid Solutions ,medicine.disease ,3126 Surgery, anesthesiology, intensive care, radiology ,SEVERE SEPSIS ,Anesthesiology and Pain Medicine ,Fluid Therapy ,business ,Follow-Up Studies - 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.
- Published
- 2020