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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial

Authors: Alexander Zarbock, Joachim Gerß, Hugo Van Aken, Andreea Boanta, John A. Kellum, Melanie Meersch

Published in: Trials | Issue 1/2016

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Abstract

Background

Acute kidney injury remains a common complication in critically ill patients and despite multiple trials and observational studies, the optimal timing for initiation of renal replacement therapy is still unclear. The early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN) study is a randomized, single-center, prospective, two-arm, parallel group trial to reduce mortality in patients with severe acute kidney injury. We describe the study design and discuss aspects of the need for a trial in this patient cohort.

Methods/design

Our plan is to randomize critically ill patients with acute kidney injury to ‘early’ or ‘late’ initiation of renal replacement therapy according to stage 2 and 3 of the KDIGO classification using a specific trial protocol. We plan to guide data collection and analysis using pre-existing definitions and testing. The primary endpoint is overall survival in a 90-day follow-up period. Secondary endpoints include 28-day, 60-day, 90-day and 1-year all-cause mortality, recovery of renal function, ICU and hospital length-of-stay. The primary analysis will be an intention-to-treat analysis; secondary analyses include treated analyses. We will also specify rules for handling data and determining outcome.

Discussion

Several challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the practice of renal replacement therapy in critically ill patients with acute kidney injury.

Trial registration

German Clinical Trials Register: DRKS00004367 (www.​germanctr.​de); 28 May 2013.
Appendix
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Metadata
Title
Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial
Authors
Alexander Zarbock
Joachim Gerß
Hugo Van Aken
Andreea Boanta
John A. Kellum
Melanie Meersch
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1249-9

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