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Title: Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI randomized controlled pilot trial.
Authors: 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
Affiliation: Intensive Care Unit, Ghent University Hospital, Ghent University, Ghent, Belgium
King's College London, Guy's & St Thomas' Hospital, Department of Critical Care, London, UK
School of Medicine, The University of Melbourne, Melbourne, Australia
Université de Lyon, CREATIS CNRS UMR5220 INSERM U1044 INSA-Lyon, Lyon, France
Critical Care and Preoperative Medicine Research Group, Centre for Translational Medicine and Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK
Intensive Care Unit, Canberra Hospital, Canberra, Australia
Australian National University Medical School, Canberra, Australia
Department of Intensive Care, Austin Health, Heidelberg, Victoria, Australia
Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
Science Service Center, Kuopio University Hospital, Kuopio, Finland..
Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland..
Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University of Innsbruck, Austria..
Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany..
Issue Date: 5-Feb-2020
EDate: 2020
Citation: Acta anaesthesiologica Scandinavica 2020; online first: 5 February
Abstract: 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. 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). This is the first multinational trial investigating the feasibility and safety of a restrictive fluid therapy regimen in critically ill patients with AKI.
DOI: 10.1111/aas.13557
ORCID: 0000-0002-3921-4423
PubMed URL: 32022904
Type: Journal Article
Subjects: acute kidney injury
critically ill
fluid balance
restrictive fluid therapy
Appears in Collections:Journal articles

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