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

Details

Serval ID
serval:BIB_29FFA3A73FC0
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial.
Journal
Acta anaesthesiologica Scandinavica
Author(s)
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.
ISSN
1399-6576 (Electronic)
ISSN-L
0001-5172
Publication state
Published
Issued date
07/2020
Peer-reviewed
Oui
Volume
64
Number
6
Pages
831-838
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
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 seven ICUs in five countries. We aim to randomize 100 critically ill patients with AKI to a restrictive fluid treatment regimen vs 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 hours 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.
clinical.trials.gov NCT03251131.
Keywords
acute kidney injury, critically ill, fluid balance, restrictive fluid therapy
Pubmed
Web of science
Open Access
Yes
Create date
06/02/2020 18:06
Last modification date
17/02/2021 7:27
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