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Clinical Practice: Mini-Review

Free Access

Standardized Renal Endpoints for Perioperative Clinical Trials: The Standardized Endpoints in Perioperative Medicine Initiative

McIlroy D.R.a · Shaw A.D.b · Myles P.S.a

Author affiliations

aDepartment of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia; bDepartment of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA

Corresponding Author

Dr. David R. McIlroy

Department of Anaesthesia and Perioperative Medicine

Alfred Hospital, 55 Commercial Road

Melbourne, VIC 3004 (Australia)

E-Mail d.mcilroy@alfred.org.au

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Nephron 2017;137:302–305

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Abstract

Perioperative acute kidney injury is a common problem. While clinical trials seek to evaluate the impact of interventions on a variety of primary and secondary endpoints with the aim of implementing this knowledge to improve perioperative outcomes, the use of valid and relevant endpoints within clinical trials is of critical importance to achieving this goal. Suitable endpoints must be validated for the study population and in light of the clinical context under investigation while also considering regulatory requirements that govern the licensing of new therapeutic agents as well as the values of patients whose outcomes we seek to improve. Heterogeneity in perioperative clinical trial endpoints and their definitions limits the ability to compare and interpret differences in outcomes across studies or to pool outcomes from different studies in meta-analysis. The Standardized Endpoints in Perioperative Medicine (StEP) initiative is an international collaboration whose goal is to identify and recommend a suite of clearly and precisely defined endpoints across multiple domains, specifically suited for use in perioperative clinical trials. The current review describes the rationale, goals and the planned pathway of the StEP renal subgroup. Development of a set of standardized and core renal endpoints, valid and relevant for use in the perioperative context, precisely defined and yet with sufficient flexibility to encourage broad uptake and application should facilitate high-quality and practice-changing perioperative research into the future.

© 2017 S. Karger AG, Basel


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Article / Publication Details

First-Page Preview
Abstract of Clinical Practice: Mini-Review

Received: April 03, 2017
Accepted: June 07, 2017
Published online: June 21, 2017
Issue release date: Published online first

Number of Print Pages: 4
Number of Figures: 0
Number of Tables: 0

ISSN: 1660-8151 (Print)
eISSN: 2235-3186 (Online)

For additional information: https://www.karger.com/NEF


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