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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

Hardeep Aujla Orcid Logo, Tracy Kumar, Marcin Woźniak, William Dott, Nikol Sullo Orcid Logo, Lathishia Joel-David, Thomas Morris, Cassandra Brookes, Shaun Barber, Gavin James Murphy

Open Heart, Volume: 5, Issue: 2, Start page: e000838

Swansea University Author: Nikol Sullo Orcid Logo

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DOI (Published version): 10.1136/openhrt-2018-000838

Abstract

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 sild...

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Published in: Open Heart
ISSN: 2053-3624
Published: BMJ 2018
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URI: https://cronfa.swan.ac.uk/Record/cronfa70512
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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. 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spelling 2025-10-10T11:02:42.5549558 v2 70512 2025-09-25 Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol a2c2be54c418e779fd6a010486e1c730 0000-0002-9885-5474 Nikol Sullo Nikol Sullo true false 2025-09-25 MEDS 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. Journal Article Open Heart 5 2 e000838 BMJ 2053-3624 18 10 2018 2018-10-18 10.1136/openhrt-2018-000838 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee 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’. 2025-10-10T11:02:42.5549558 2025-09-25T14:49:46.6626118 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Hardeep Aujla 0000-0002-5823-848x 1 Tracy Kumar 2 Marcin Woźniak 3 William Dott 4 Nikol Sullo 0000-0002-9885-5474 5 Lathishia Joel-David 6 Thomas Morris 7 Cassandra Brookes 8 Shaun Barber 9 Gavin James Murphy 10 70512__35303__65c00a7b322a43bea00f17d047b4a408.pdf 70512.VoR.pdf 2025-10-10T10:58:47.3968356 Output 377003 application/pdf Version of Record true © Author(s) (or their employer(s)) 2018. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license. true eng http://creativecommons.org/licenses/by/4.0/
title Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol
spellingShingle Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol
Nikol Sullo
title_short Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol
title_full Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol
title_fullStr Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol
title_full_unstemmed Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol
title_sort Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol
author_id_str_mv a2c2be54c418e779fd6a010486e1c730
author_id_fullname_str_mv a2c2be54c418e779fd6a010486e1c730_***_Nikol Sullo
author Nikol Sullo
author2 Hardeep Aujla
Tracy Kumar
Marcin Woźniak
William Dott
Nikol Sullo
Lathishia Joel-David
Thomas Morris
Cassandra Brookes
Shaun Barber
Gavin James Murphy
format Journal article
container_title Open Heart
container_volume 5
container_issue 2
container_start_page e000838
publishDate 2018
institution Swansea University
issn 2053-3624
doi_str_mv 10.1136/openhrt-2018-000838
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
document_store_str 1
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description 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.
published_date 2018-10-18T05:31:01Z
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