Amit X Garg1, Matthew T V Chan2, Meaghan S Cuerden2, P J Devereaux2, Seyed Hesameddin Abbasi2, Ainslie Hildebrand2, François Lamontagne2, Andre Lamy2, Nicolas Noiseux2, Chirag R Parikh2, Vlado Perkovic2, Mackenzie Quantz2, Antoine Rochon2, Alistair Royse2, Daniel I Sessler2, Pallav J Shah2, Jessica M Sontrop2, Georgios I Tagarakis2, Kevin H Teoh2, Jessica Vincent2, Michael Walsh2, Jean-Pierre Yared2, Salim Yusuf2, Richard P Whitlock2. 1. Division of Nephrology (Garg, Cuerden, Sontrop), Department of Medicine, London Health Sciences Centre, London, Ont.; Department of Anaesthesia and Intensive Care (Chan), The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China; Departments of Health Research Methods, Evidence, and Impact, and Medicine (Devereaux, Walsh), McMaster University, Hamilton, Ont.; Tehran Heart Center (Abbasi), Tehran University of Medical Sciences, Tehran, Iran; Division of Nephrology (Hildebrand), Department of Medicine, University of Alberta, Edmonton, Alta.; Département de médecine (Lamontagne), Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, Que.; Department of Surgery (Lamy) McMaster University, Hamilton, Ont.; Department of Cardiac Surgery (Noiseux), Université de Montréal, Montréal, Que.; Division of Nephrology, Johns Hopkins School of Medicine (Parikh), Baltimore, Md.; The George Institute for Global Health (Perkovic), Sydney, Australia; Division of Cardiac Surgery (Quantz), London Health Sciences Centre, University Hospital, London, Ont.; Montreal Heart Institute (Rochon), Université de Montréal, Montréal, Que.; Department of Surgery (Royse), University of Melbourne, Melbourne, Australia; Department of Outcomes Research (Sessler), Cleveland Clinic, Cleveland, Ohio; Department of Cardiac Surgery (Shah), Princess Alexandra Hospital, Brisbane, Australia; Department of Cardiovascular and Thoracic Surgery (Tagarakis), Aristotle University of Thessaloniki, Thessaloniki, Greece; Division of Cardiac Surgery (Teoh), Southlake Regional Health Centre, Newmarket, Ont.; Population Health Research Institute (Vincent, Whitlock), Hamilton, Ont.; Department of Cardiothoracic Anesthesiology (Yared), Cleveland Clinic, Cleveland, Ohio; Division of Cardiology (Yusuf), Department of Medicine, McMaster University, Hamilton, Ont. amit.garg@lhsc.on.ca. 2. Division of Nephrology (Garg, Cuerden, Sontrop), Department of Medicine, London Health Sciences Centre, London, Ont.; Department of Anaesthesia and Intensive Care (Chan), The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China; Departments of Health Research Methods, Evidence, and Impact, and Medicine (Devereaux, Walsh), McMaster University, Hamilton, Ont.; Tehran Heart Center (Abbasi), Tehran University of Medical Sciences, Tehran, Iran; Division of Nephrology (Hildebrand), Department of Medicine, University of Alberta, Edmonton, Alta.; Département de médecine (Lamontagne), Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, Que.; Department of Surgery (Lamy) McMaster University, Hamilton, Ont.; Department of Cardiac Surgery (Noiseux), Université de Montréal, Montréal, Que.; Division of Nephrology, Johns Hopkins School of Medicine (Parikh), Baltimore, Md.; The George Institute for Global Health (Perkovic), Sydney, Australia; Division of Cardiac Surgery (Quantz), London Health Sciences Centre, University Hospital, London, Ont.; Montreal Heart Institute (Rochon), Université de Montréal, Montréal, Que.; Department of Surgery (Royse), University of Melbourne, Melbourne, Australia; Department of Outcomes Research (Sessler), Cleveland Clinic, Cleveland, Ohio; Department of Cardiac Surgery (Shah), Princess Alexandra Hospital, Brisbane, Australia; Department of Cardiovascular and Thoracic Surgery (Tagarakis), Aristotle University of Thessaloniki, Thessaloniki, Greece; Division of Cardiac Surgery (Teoh), Southlake Regional Health Centre, Newmarket, Ont.; Population Health Research Institute (Vincent, Whitlock), Hamilton, Ont.; Department of Cardiothoracic Anesthesiology (Yared), Cleveland Clinic, Cleveland, Ohio; Division of Cardiology (Yusuf), Department of Medicine, McMaster University, Hamilton, Ont.
Abstract
BACKGROUND: Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery. METHODS: We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007-2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients (n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 μmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery. RESULTS:Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease. INTERPRETATION:Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov, no. NCT00427388.
RCT Entities:
BACKGROUND: Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery. METHODS: We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007-2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients (n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 μmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery. RESULTS:Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease. INTERPRETATION: Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov, no. NCT00427388.
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