Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: renal endpoints

Renal injury is a common perioperative complication. The adoption of renal endpoints, standardised and valid for use in perioperative clinical trials, would enhance the quality of perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established...

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Bibliographic Details
Published in:British journal of anaesthesia : BJA Vol. 121; no. 5; p. 1013
Main Authors: McIlroy, D R, Bellomo, R, Billings, 4th, F T, Karkouti, K, Prowle, J R, Shaw, A D, Myles, P S
Format: Journal Article
Language:English
Published: England 01.11.2018
Subjects:
Acute Kidney Injury - diagnosis
Acute Kidney Injury - etiology
Clinical Trials as Topic - standards
Consensus
Endpoint Determination - standards
Humans
Kidney
Kidney Function Tests - standards
Outcome Assessment (Health Care)
Perioperative Care - standards
Reference Standards
kidney
postoperative outcomes
complications
outcome measures
clinical trials
anaesthesia
surgery
ISSN:1471-6771, 1471-6771
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Summary:Renal injury is a common perioperative complication. The adoption of renal endpoints, standardised and valid for use in perioperative clinical trials, would enhance the quality of perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in perioperative clinical trials. A systematic review was conducted to identify renal endpoints currently reported in perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended perioperative renal outcome measures. Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite. We identified four key renal outcome measures that should be considered for use in perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials.
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ISSN:1471-6771
1471-6771
DOI:10.1016/j.bja.2018.08.010