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Randomized Controlled Trial
Effects of remote ischemic preconditioning in high-risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial.
- Michael Walsh, Richard Whitlock, Amit X Garg, Jean-François Légaré, Andra E Duncan, Robert Zimmerman, Scott Miller, Stephen Fremes, Teresa Kieser, Ganesan Karthikeyan, Matthew Chan, Anthony Ho, Vivian Nasr, Jessica Vincent, Imtiaz Ali, Ronit Lavi, Daniel I Sessler, Robert Kramer, Jeff Gardner, Summer Syed, Tomas VanHelder, Gordon Guyatt, Purnima Rao-Melacini, Lehana Thabane, P J Devereaux, and Remote IMPACT Investigators.
- Population Health Research Institute (Walsh, Whitlock, Vincent, Rao-Melacini, Thabane, Devereaux), Hamilton, Ont.; McMaster University (Walsh, Whitlock, Syed, VanHelder, Guyatt, Rao-Melacini, Thabane, Devereaux), Hamilton, Ont.; London Health Sciences Centre (Garg, Lavi), Western University, London, Ont.; Dalhousie University (Légaré), Halifax, NS; Cleveland Clinic (Duncan, Nasr, Sessler), Cleveland, Ohio; Maine Medical Center (Zimmerman, Kramer), Portland, Me.; Wake Forest University (Miller, Gardner), Winston-Salem, NC; Sunnybrook Health Sciences Centre (Fremes), University of Toronto, Toronto, Ont.; University of Calgary (Kieser, Ali), Calgary, Alta.; All India Institute of Medical Sciences (Karthikeyan), New Delhi, India; The Chinese University of Hong Kong (Chan, Ho), Hong Kong SAR, China lastwalsh1975@gmail.com.
- CMAJ. 2016 Mar 15; 188 (5): 329-36.
BackgroundRemote ischemic preconditioning is a simple therapy that may reduce cardiac and kidney injury. We undertook a randomized controlled trial to evaluate the effect of this therapy on markers of heart and kidney injury after cardiac surgery.MethodsPatients at high risk of death within 30 days after cardiac surgery were randomly assigned to undergo remote ischemic preconditioning or a sham procedure after induction of anesthesia. The preconditioning therapy was three 5-minute cycles of thigh ischemia, with 5 minutes of reperfusion between cycles. The sham procedure was identical except that ischemia was not induced. The primary outcome was peak creatine kinase-myocardial band (CK-MB) within 24 hours after surgery (expressed as multiples of the upper limit of normal, with log transformation). The secondary outcome was change in creatinine level within 4 days after surgery (expressed as log-transformed micromoles per litre). Patient-important outcomes were assessed up to 6 months after randomization.ResultsWe randomly assigned 128 patients to remote ischemic preconditioning and 130 to the sham therapy. There were no significant differences in postoperative CK-MB (absolute mean difference 0.15, 95% confidence interval [CI] -0.07 to 0.36) or creatinine (absolute mean difference 0.06, 95% CI -0.10 to 0.23). Other outcomes did not differ significantly for remote ischemic preconditioning relative to the sham therapy: for myocardial infarction, relative risk (RR) 1.35 (95% CI 0.85 to 2.17); for acute kidney injury, RR 1.10 (95% CI 0.68 to 1.78); for stroke, RR 1.02 (95% CI 0.34 to 3.07); and for death, RR 1.47 (95% CI 0.65 to 3.31).InterpretationRemote ischemic precnditioning did not reduce myocardial or kidney injury during cardiac surgery. This type of therapy is unlikely to substantially improve patient-important outcomes in cardiac surgery.Trial RegistrationClinicalTrials.gov, no. NCT01071265.© 2016 Canadian Medical Association or its licensors.
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