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 trialReportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 17:148

First Online: 18 March 2016Received: 10 April 2015Accepted: 23 February 2016DOI: 10.1186-s13063-016-1249-9

Cite this article as: Zarbock, A., Gerß, J., Van Aken, H. et al. Trials 2016 17: 148. doi:10.1186-s13063-016-1249-9

Abstract

BackgroundAcute 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-designOur 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.

DiscussionSeveral 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 registrationGerman Clinical Trials Register: DRKS00004367 www.germanctr.de; 28 May 2013.

KeywordsCritically ill patients Renal replacement therapy Acute kidney injury Clinical trial AbbreviationsAKIacute kidney injury

AKINAcute Kidney Injury Network

APACHEAcute Physiology and Chronic Health Evaluation

BUNblood urea nitrogen

CREPconditional rejection error probability

CRFcase report form

ECGelectrocardiogram

ELAINearly versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury

GFRglomerular filtration rate

ICUintensive care unit

KDIGOKidney Disease: Improving Global Outcomes

NGALneutrophil gelatinase-associated lipocalin

RRTrenal replacement therapy

SOFASequential Organ Failure Assessment

SOPstandard operating procedure.

Alexander Zarbock and Joachim Gerß share first authorship.

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1249-9 contains supplementary material, which is available to authorized users.

An erratum to this article can be found at http:-dx.doi.org-10.1186-s13063-016-1386-1.

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

Fuente: https://link.springer.com/







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