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Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial

Tracy Kumar, Hardeep Aujla, Marcin Woźniak, Will Dott, Nikol Sullo Orcid Logo, Lathishia Joel-David, Paolo Pais, Dawn Smallwood, Douglas Miller, Bryony Eagle-Hemming, Ana Suazo Di Paola, Shaun Barber, Cassandra Brookes, Nigel J. Brunskill, Gavin J. Murphy

British Journal of Anaesthesia, Volume: 124, Issue: 6, Pages: 693 - 701

Swansea University Author: Nikol Sullo Orcid Logo

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DOI (Published version): 10.1016/j.bja.2020.01.030

Abstract

BackgroundThis study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass.MethodsIn a double-blind RCT, adults at increased risk of acute kidney injury undergoing cardiac surgery in a single UK tertiary cent...

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Published in: British Journal of Anaesthesia
ISSN: 0007-0912
Published: Elsevier BV 2020
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URI: https://cronfa.swan.ac.uk/Record/cronfa70509
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The primary outcome was serum creatinine measured at six post-randomisation time points. The primary analysis used a linear mixed-effects model adjusted for the stratification variables, baseline estimated glomerular filtration rate, and surgical procedure. Secondary outcomes considered clinical events and potential disease mechanisms. Effect estimates were expressed as mean differences (MDs) or odds ratios with 95% confidence intervals.ResultsThe analysis population comprised eligible randomised patients that underwent valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass, between May 2015 and June 2018. There were 60 subjects in the sildenafil group and 69 in the placebo control group. The difference between groups in creatinine concentration was not statistically significant (MD: 0.88 &#x3BC;mol L&#x2212;1 [&#x2013;5.82, 7.59]). There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044). Secondary outcomes, and biomarkers of kidney injury, endothelial function, and inflammatory cell activation, were not significantly different between the groups.ConclusionsThese results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery.</abstract><type>Journal Article</type><journal>British Journal of Anaesthesia</journal><volume>124</volume><journalNumber>6</journalNumber><paginationStart>693</paginationStart><paginationEnd>701</paginationEnd><publisher>Elsevier BV</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>0007-0912</issnPrint><issnElectronic/><keywords>acute kidney injury; cardiac surgery; cardiopulmonary bypass; phosphodiesterase type 5 inhibitors; renal protection; sildenafil citrate</keywords><publishedDay>1</publishedDay><publishedMonth>6</publishedMonth><publishedYear>2020</publishedYear><publishedDate>2020-06-01</publishedDate><doi>10.1016/j.bja.2020.01.030</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>British Heart Foundation (RG/13/6/29947), (CH/12/1/29419) to GJM, MW, TK, and HA; Leicester and Bristol National Institute for Health Research Cardiovascular Biomedical Research Units.</funders><projectreference/><lastEdited>2025-10-10T11:46:02.3323265</lastEdited><Created>2025-09-25T14:48:43.6258409</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Biomedical Science</level></path><authors><author><firstname>Tracy</firstname><surname>Kumar</surname><order>1</order></author><author><firstname>Hardeep</firstname><surname>Aujla</surname><order>2</order></author><author><firstname>Marcin</firstname><surname>Wo&#x17A;niak</surname><order>3</order></author><author><firstname>Will</firstname><surname>Dott</surname><order>4</order></author><author><firstname>Nikol</firstname><surname>Sullo</surname><orcid>0000-0002-9885-5474</orcid><order>5</order></author><author><firstname>Lathishia</firstname><surname>Joel-David</surname><order>6</order></author><author><firstname>Paolo</firstname><surname>Pais</surname><order>7</order></author><author><firstname>Dawn</firstname><surname>Smallwood</surname><order>8</order></author><author><firstname>Douglas</firstname><surname>Miller</surname><order>9</order></author><author><firstname>Bryony</firstname><surname>Eagle-Hemming</surname><order>10</order></author><author><firstname>Ana Suazo Di</firstname><surname>Paola</surname><order>11</order></author><author><firstname>Shaun</firstname><surname>Barber</surname><order>12</order></author><author><firstname>Cassandra</firstname><surname>Brookes</surname><order>13</order></author><author><firstname>Nigel J.</firstname><surname>Brunskill</surname><order>14</order></author><author><firstname>Gavin J.</firstname><surname>Murphy</surname><order>15</order></author></authors><documents><document><filename>70509__35305__5b0f5d6a7b504dc09e08066b74c86fed.pdf</filename><originalFilename>70509.VoR.pdf</originalFilename><uploaded>2025-10-10T11:42:24.8226920</uploaded><type>Output</type><contentLength>635448</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>&#xA9; 2020 The Author(s). 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spelling 2025-10-10T11:46:02.3323265 v2 70509 2025-09-25 Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial a2c2be54c418e779fd6a010486e1c730 0000-0002-9885-5474 Nikol Sullo Nikol Sullo true false 2025-09-25 MEDS BackgroundThis study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass.MethodsIn a double-blind RCT, adults at increased risk of acute kidney injury undergoing cardiac surgery in a single UK tertiary centre were randomised to receive sildenafil citrate 12.5 mg kg−1 i.v. over 150 min or dextrose 5% at the commencement of surgery. The primary outcome was serum creatinine measured at six post-randomisation time points. The primary analysis used a linear mixed-effects model adjusted for the stratification variables, baseline estimated glomerular filtration rate, and surgical procedure. Secondary outcomes considered clinical events and potential disease mechanisms. Effect estimates were expressed as mean differences (MDs) or odds ratios with 95% confidence intervals.ResultsThe analysis population comprised eligible randomised patients that underwent valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass, between May 2015 and June 2018. There were 60 subjects in the sildenafil group and 69 in the placebo control group. The difference between groups in creatinine concentration was not statistically significant (MD: 0.88 μmol L−1 [–5.82, 7.59]). There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044). Secondary outcomes, and biomarkers of kidney injury, endothelial function, and inflammatory cell activation, were not significantly different between the groups.ConclusionsThese results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery. Journal Article British Journal of Anaesthesia 124 6 693 701 Elsevier BV 0007-0912 acute kidney injury; cardiac surgery; cardiopulmonary bypass; phosphodiesterase type 5 inhibitors; renal protection; sildenafil citrate 1 6 2020 2020-06-01 10.1016/j.bja.2020.01.030 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee British Heart Foundation (RG/13/6/29947), (CH/12/1/29419) to GJM, MW, TK, and HA; Leicester and Bristol National Institute for Health Research Cardiovascular Biomedical Research Units. 2025-10-10T11:46:02.3323265 2025-09-25T14:48:43.6258409 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Tracy Kumar 1 Hardeep Aujla 2 Marcin Woźniak 3 Will Dott 4 Nikol Sullo 0000-0002-9885-5474 5 Lathishia Joel-David 6 Paolo Pais 7 Dawn Smallwood 8 Douglas Miller 9 Bryony Eagle-Hemming 10 Ana Suazo Di Paola 11 Shaun Barber 12 Cassandra Brookes 13 Nigel J. Brunskill 14 Gavin J. Murphy 15 70509__35305__5b0f5d6a7b504dc09e08066b74c86fed.pdf 70509.VoR.pdf 2025-10-10T11:42:24.8226920 Output 635448 application/pdf Version of Record true © 2020 The Author(s). This is an open access article under the CC BY license. true eng http://creativecommons.org/licenses/by/4.0/
title Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
spellingShingle Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
Nikol Sullo
title_short Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
title_full Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
title_fullStr Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
title_full_unstemmed Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
title_sort Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
author_id_str_mv a2c2be54c418e779fd6a010486e1c730
author_id_fullname_str_mv a2c2be54c418e779fd6a010486e1c730_***_Nikol Sullo
author Nikol Sullo
author2 Tracy Kumar
Hardeep Aujla
Marcin Woźniak
Will Dott
Nikol Sullo
Lathishia Joel-David
Paolo Pais
Dawn Smallwood
Douglas Miller
Bryony Eagle-Hemming
Ana Suazo Di Paola
Shaun Barber
Cassandra Brookes
Nigel J. Brunskill
Gavin J. Murphy
format Journal article
container_title British Journal of Anaesthesia
container_volume 124
container_issue 6
container_start_page 693
publishDate 2020
institution Swansea University
issn 0007-0912
doi_str_mv 10.1016/j.bja.2020.01.030
publisher Elsevier BV
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
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
active_str 0
description BackgroundThis study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass.MethodsIn a double-blind RCT, adults at increased risk of acute kidney injury undergoing cardiac surgery in a single UK tertiary centre were randomised to receive sildenafil citrate 12.5 mg kg−1 i.v. over 150 min or dextrose 5% at the commencement of surgery. The primary outcome was serum creatinine measured at six post-randomisation time points. The primary analysis used a linear mixed-effects model adjusted for the stratification variables, baseline estimated glomerular filtration rate, and surgical procedure. Secondary outcomes considered clinical events and potential disease mechanisms. Effect estimates were expressed as mean differences (MDs) or odds ratios with 95% confidence intervals.ResultsThe analysis population comprised eligible randomised patients that underwent valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass, between May 2015 and June 2018. There were 60 subjects in the sildenafil group and 69 in the placebo control group. The difference between groups in creatinine concentration was not statistically significant (MD: 0.88 μmol L−1 [–5.82, 7.59]). There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044). Secondary outcomes, and biomarkers of kidney injury, endothelial function, and inflammatory cell activation, were not significantly different between the groups.ConclusionsThese results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery.
published_date 2020-06-01T05:31:00Z
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