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Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol

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posted on 2019-06-19, 11:46 authored by H Aujla, T Kumar, M Woźniak, W Dott, N Sullo, L Joel-David, T Morris, C Brookes, S Barber, GJ Murphy
Introduction: Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. The administration of pharmacological renoprotective agents during the perioperative period could prevent or reduce the severity of AKI and improve clinical outcomes. Experimental studies suggest that sildenafil may have therapeutic potential for the prevention of AKI. This trial will test the hypothesis that postoperative AKI will be reduced in cardiac surgery patients if they receive sildenafil compared with placebo. Methods and analysis: Adult cardiac surgery patients 18 years of age or above undergoing cardiac surgery with cardiopulmonary bypass and cardioplegic arrest at a single tertiary cardiac centre in the UK will be randomised in a 1:1 ratio to receive either sildenafil or placebo. The primary outcome is serum creatinine concentration measured at preoperation and daily for up to 7 days postoperatively. Secondary outcomes will include measures of inflammation, organ injury, volumes of blood transfused and resource use. Allocation concealment, internet-based randomisation stratified by operation type, and blinding of outcome assessors will reduce the risk of bias. A sample size of 112 patients will have a 90% power to detect a mean difference of 10 μmol/L for serum creatinine values between treatment and placebo control groups with an alpha value of 0.05. Ethics and dissemination: The trial protocol was approved by a UK ethics committee (reference 15/YH/0489). The trial findings will be disseminated in scientific journals and meetings. Trial registration number: ISRCTN18386427.

Funding

The REVAKI-2 trial is part of a British Heart Foundation grant (grant reference no. RG/13/6/29947) for a programme of work titled ‘Towards the prevention of post cardiac surgery AKI’.

History

Citation

Open Heart, 2018; 5:e000838

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Cardiovascular Sciences

Version

  • VoR (Version of Record)

Published in

Open Heart

Publisher

BMJ Publishing Group

issn

2053-3624

Acceptance date

2018-07-24

Copyright date

2018

Available date

2019-06-19

Notes

The data from the REVAKI-2 study will be available for further ethically approved research studies.

Language

en

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