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NDT Advance Access published online on October 7, 2009
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfp501
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© The Author 2009. Published by Oxford University Press [on behalf of ERA-EDTA]. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


Outcome definitions in non-dialysis intervention and prevention trials in acute kidney injury (AKI)

Zoltán H. Endre and John W. Pickering

Department of Medicine, Christchurch Kidney Research Group, University of Otago, Christchurch, New Zealand

Correspondence and offprint requests to: Zoltán H Endre; E-mail: Rowena.fisher{at}otago.ac.nz



  Abstract

Background. The risk, injury, failure, loss-of-function, end-stage-renal-failure (RIFLE) and acute kidney injury network (AKIN) consensus definitions of acute kidney injury (AKI) were established in part to facilitate comparison of trials. Contrast-induced nephropathy (CIN) has traditionally used a less demanding definition.

Objectives. To review use of RIFLE and AKIN as AKI trial outcome variables and contrast these with outcomes for CIN.

Methods. We conducted a search of PubMed from 1 January 2005 to 31 December 2008 and 9 trial registries for randomized control trials for preventional or interventional treatment of AKI and CIN.

Results. RIFLE or AKIN were outcome variables in 36% (n = 8) of the published (n = 22) and 18% (n = 4) of the current (n = 22) AKI trials. RIFLE was used to triage to intervention in three trials. The urine output definition of RIFLE and AKIN was an outcome in only two trials. In 18% (n = 8) of AKI trials, the CIN definition (increase in serum creatinine of ≥25% and/or ≥44 µmol/l) was the primary outcome. This was also the primary outcome in 56% (n = 13) of published (n = 12) and current (n = 11) CIN trials. Three published CIN trials used RIFLE or AKIN as an outcome (13%). The duration over which outcomes were determined varied from 24 h to 7 days.

Conclusions. Considerable heterogeneity remains in outcome variables of AKI and CIN clinical trials. Even when the RIFLE or AKIN criteria were used, they were not applied consistently. There is a need for further consensus on surrogate outcome variables.

Keywords: acute renal failure; biomarkers; clinical trials; intervention; prevention

Received for publication: 29. 4.09
Accepted in revised form: 28. 8.09


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