Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial
Introduction Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump. At the time of surgery, compared with placebo, methylprednisolone divided...
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BMJ Publishing Group
2014-03-01
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| author | Michael Walsh Salim Yusuf Chirag Parikh Jessica Vincent P J Devereaux Francois Lamontagne Matthew T V Chan Richard Whitlock Meaghan Cuerden Amit X Garg Andre Lamy Daniel I Sessler Kevin Teoh Ainslie Hildebrand Yunxia Zuo Pallav Shah Seyed Hesameddin Abbasi Mackenzie Quantz Jean-Pierre Yared Nicolas Noiseux Georgios Tagarakis Antoine Rochon Janice Pogue Abbas Salehiomran |
| author_facet | Michael Walsh Salim Yusuf Chirag Parikh Jessica Vincent P J Devereaux Francois Lamontagne Matthew T V Chan Richard Whitlock Meaghan Cuerden Amit X Garg Andre Lamy Daniel I Sessler Kevin Teoh Ainslie Hildebrand Yunxia Zuo Pallav Shah Seyed Hesameddin Abbasi Mackenzie Quantz Jean-Pierre Yared Nicolas Noiseux Georgios Tagarakis Antoine Rochon Janice Pogue Abbas Salehiomran |
| collection | DOAJ |
| description | Introduction Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump. At the time of surgery, compared with placebo, methylprednisolone divided into two intravenous doses of 250 mg each may reduce the risk of postoperative acute kidney injury (AKI).Methods and analysis With respect to the study schedule, over 7000 substudy eligible patients from 81 centres in 18 countries were randomised in December 2013. The authors will use a logistic regression to estimate the adjusted OR of methylprednisolone versus placebo on the primary outcome of AKI in the 14 days following surgery (a postoperative increase in serum creatinine of ≥50%, or ≥26.5 μmol/L, from the preoperative value). The stage of AKI will also be considered, as will the outcome of AKI in those with and without preoperative chronic kidney disease. After receipt of grant funding, the authors began to record additional perioperative serum creatinine measurements in consecutive patients enrolled at substudy participating centres, and patients were invited to enroll in a 6-month serum creatinine collection. In these trial subpopulations, the authors will consider the outcome of AKI defined in alternate ways, and the outcome of a 6-month change in kidney function from the preoperative value.Ethics and dissemination The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this SIRS AKI substudy. Ethics approval was obtained for additional serum creatinine recordings in consecutive patients enrolled at participating centres. The additional kidney data collection first began for patients enrolled after 1 March 2012. In patients who provided consent, the last 6-month kidney outcome data will be collected in 2014. The results will be reported no later than 2015.Clinical Trial Registration Number NCT00427388. |
| format | Article |
| id | doaj-art-6d58af39ba5e4efcb17c6b82b7319322 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2014-03-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-6d58af39ba5e4efcb17c6b82b73193222025-02-11T23:55:10ZengBMJ Publishing GroupBMJ Open2044-60552014-03-014310.1136/bmjopen-2014-004842Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial 0Michael Walsh1Salim Yusuf2Chirag Parikh3Jessica Vincent4P J Devereaux5Francois Lamontagne6Matthew T V Chan7Richard Whitlock8Meaghan Cuerden9Amit X Garg10Andre Lamy11Daniel I Sessler12Kevin Teoh13Ainslie Hildebrand14Yunxia Zuo15Pallav Shah16Seyed Hesameddin Abbasi17Mackenzie Quantz18Jean-Pierre Yared19Nicolas Noiseux20Georgios Tagarakis21Antoine Rochon22Janice Pogue23Abbas Salehiomran24Kenya National Bureau of Statistics, Nairobi, Nairobi, Kenyaassociate professorPopulation Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, CanadaDivision of Nephrology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA2Population Health Research Institute/McMaster University/Hamilton Health Sciences, Hamilton, Canadaclinical scholarassistant professorAnaesthesia and Intensive Care, Chinese University of Hong Kong, New Territories, Hong KongSurgery, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada3University of Waterloo, Waterloo, Canada1 Department of Medicine, Western University, London, Ontario, CanadaDepartment for Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Duisburg-Essen, Essen, Germanyprofessor1 Department of Organizational Psychology, Birkbeck University of London, London, UK5Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USADepartment of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaRoyal Brompton and Harefield NHS Foundation Trust, London, UK8Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran1Western University, London, Canada5Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USADivision of Cardiac Surgery, Universite de Montreal, Montreal, Québec, Canada10University of Thessaly, Larissa, Greece11Montreal Heart Institute, Montréal, Canada1Western University, London, Canada8Tehran Heart Center, Tehran University of Medical Sciences, Tehran, IranIntroduction Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump. At the time of surgery, compared with placebo, methylprednisolone divided into two intravenous doses of 250 mg each may reduce the risk of postoperative acute kidney injury (AKI).Methods and analysis With respect to the study schedule, over 7000 substudy eligible patients from 81 centres in 18 countries were randomised in December 2013. The authors will use a logistic regression to estimate the adjusted OR of methylprednisolone versus placebo on the primary outcome of AKI in the 14 days following surgery (a postoperative increase in serum creatinine of ≥50%, or ≥26.5 μmol/L, from the preoperative value). The stage of AKI will also be considered, as will the outcome of AKI in those with and without preoperative chronic kidney disease. After receipt of grant funding, the authors began to record additional perioperative serum creatinine measurements in consecutive patients enrolled at substudy participating centres, and patients were invited to enroll in a 6-month serum creatinine collection. In these trial subpopulations, the authors will consider the outcome of AKI defined in alternate ways, and the outcome of a 6-month change in kidney function from the preoperative value.Ethics and dissemination The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this SIRS AKI substudy. Ethics approval was obtained for additional serum creatinine recordings in consecutive patients enrolled at participating centres. The additional kidney data collection first began for patients enrolled after 1 March 2012. In patients who provided consent, the last 6-month kidney outcome data will be collected in 2014. The results will be reported no later than 2015.Clinical Trial Registration Number NCT00427388.https://bmjopen.bmj.com/content/4/3/e004842.full |
| spellingShingle | Michael Walsh Salim Yusuf Chirag Parikh Jessica Vincent P J Devereaux Francois Lamontagne Matthew T V Chan Richard Whitlock Meaghan Cuerden Amit X Garg Andre Lamy Daniel I Sessler Kevin Teoh Ainslie Hildebrand Yunxia Zuo Pallav Shah Seyed Hesameddin Abbasi Mackenzie Quantz Jean-Pierre Yared Nicolas Noiseux Georgios Tagarakis Antoine Rochon Janice Pogue Abbas Salehiomran Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial BMJ Open |
| title | Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial |
| title_full | Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial |
| title_fullStr | Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial |
| title_full_unstemmed | Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial |
| title_short | Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial |
| title_sort | steroids in cardiac surgery sirs trial acute kidney injury substudy protocol of an international randomised controlled trial |
| url | https://bmjopen.bmj.com/content/4/3/e004842.full |
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