Effects of remote ischemic preconditioning in high-risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial.

Abstract

BACKGROUND:

Remote 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.

METHODS:

Patients 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.

RESULTS:

We 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).

INTERPRETATION:

Remote 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 REGISTRATION:

ClinicalTrials.gov, no. NCT01071265.

• Authors: 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, Remote IMPACT Investigators
• Journal: CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne (CMAJ) Vol. 188 Issue 5 Pg. 329-336 (Mar 15 2016) ISSN: 1488-2329 [Electronic] Canada
• PMID: 26668200 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 Canadian Medical Association or its licensors.

Chemical References

• Biomarkers
• Creatinine
• Creatine Kinase, MB Form

Topics

• Acute Kidney Injury (blood, prevention & control)
• Aged
• Aged, 80 and over
• Biomarkers (blood)
• Cardiac Surgical Procedures (methods)
• Coronary Artery Bypass
• Creatine Kinase, MB Form (blood)
• Creatinine (blood)
• Female
• Heart Valves (surgery)
• Humans
• Ischemic Preconditioning (methods)
• Male
• Middle Aged
• Myocardial Reperfusion Injury (blood, prevention & control)
• Postoperative Complications (blood, prevention & control)
• Reperfusion Injury (blood, prevention & control)
• Single-Blind Method
• Treatment Outcome