Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury – REVERSE-AKI randomized controlled pilot trial

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Vaara , S T , Ostermann , M , Selander , T , Bitker , L , Schneider , A , Poli , E , Hoste , E , Joannidis , M , Zarbock , A , van Haren , F , Prowle , J , Pettilä , V & Bellomo , R 2020 , ' Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury – REVERSE-AKI randomized controlled pilot trial ' , Acta Anaesthesiologica Scandinavica , vol. 64 , no. 6 , pp. 831-838 . https://doi.org/10.1111/aas.13557

Title: Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury – REVERSE-AKI randomized controlled pilot trial
Author: Vaara, Suvi T.; Ostermann, Marlies; Selander, Tuomas; Bitker, Laurent; Schneider, Antoine; Poli, Elettra; Hoste, Eric; Joannidis, Michael; Zarbock, Alexander; van Haren, Frank; Prowle, John; Pettilä, Ville; Bellomo, Rinaldo
Contributor: University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, Department of Diagnostics and Therapeutics
Date: 2020-07
Language: eng
Number of pages: 8
Belongs to series: Acta Anaesthesiologica Scandinavica
ISSN: 0001-5172
URI: http://hdl.handle.net/10138/316740
Abstract: Abstract Background Fluid accumulation frequently coexists with acute kidney injury (AKI) and is associated with increased risk for AKI progression and mortality. Among septic shock patients, restricted use of resuscitation fluid has been reported to reduce the risk of worsening of AKI. Restrictive fluid therapy, however, has not been studied in the setting of established AKI. Here, we present the protocol and statistical analysis plan of the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury - the REVERSE-AKI trial that compares a restrictive fluid therapy regimen to standard therapy in critically ill patients with AKI. Methods REVERSE-AKI is an investigator-initiated, multinational, open-label, randomized, controlled, feasibility pilot trial conducted in 7 ICUs in 5 countries. We aim to randomize 100 critically ill patients with AKI to a restrictive fluid treatment regimen versus standard management. In the restrictive fluid therapy regimen, the daily fluid balance target is neutral or negative. The primary outcome is the cumulative fluid balance assessed after 72 hrs from randomization. Secondary outcomes include safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence). Conclusions This is the first multinational trial investigating the feasibility and safety of a restrictive fluid therapy regimen in critically ill patients with AKI.
Subject: acute kidney injury
critically ill
fluid balance
restrictive fluid therapy
MANAGEMENT
PARALLEL-GROUP
SEPTIC SHOCK
ACCUMULATION
CRITICALLY-ILL PATIENTS
RESUSCITATION
3126 Surgery, anesthesiology, intensive care, radiology
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