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

CMAJ. 2016 Mar 15;188(5):329-336. doi: 10.1503/cmaj.150632. Epub 2015 Dec 14.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Kidney Injury / blood
  • Acute Kidney Injury / 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
  • Myocardial Reperfusion Injury / prevention & control*
  • Postoperative Complications / blood
  • Postoperative Complications / prevention & control*
  • Reperfusion Injury / blood
  • Reperfusion Injury / prevention & control
  • Single-Blind Method
  • Treatment Outcome

Substances

  • Biomarkers
  • Creatinine
  • Creatine Kinase, MB Form

Associated data

  • ClinicalTrials.gov/NCT01071265