Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest

University Hospital, Essen1,204 enrolled

Overview

Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.

Remote ischemic preconditioning (RIPC) protocol after induction of anesthesia and before skin incision consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and at 10 minutes after aortic unclamping during reperfusion of the myocardium.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,204

Conditions

Myocardial Injury

Interventions

RIPCPROCEDURE

3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion

ControlPROCEDURE

Coronary artery bypass surgery without remote ischemic preconditioning protocol

isoflurane+sufentanil anesthesiaDRUG

Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consecutive patients \>18 years of age * Double- or triple-vessel coronary artery disease * Elective isolated first-time CABG * Combined valve surgery + CABG * Written informed consent Exclusion Criteria: * Renal failure (creatinine ≥ 200 µmol/L) * Peripheral vascular disease affecting upper limbs * Preoperative inotropic support * Any kind of mechanical assist device * Acute or recent (\<4 weeks) acute coronary syndromes * Any PCI (\<6 weeks) * Any reasons for preoperative cTnI elevation * Emergency surgery * Redo surgery

Locations (1)

Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, University Duisburg-Essen

Essen, Germany

Outcomes

Primary Outcomes

Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC).

Time frame: 72 hours postoperatively after CABG surgery

Secondary Outcomes

All-cause mortality

Time frame: 30 days and 1 year and complete follow-up after CABG surgery

Major adverse cardiac and cerebrovascular events (MACCE)

Time frame: at 30 days and 1 year and complete follow-up after CABG surgery

Myocardial infarction

Time frame: 30 days and 1 year and complete follow-up after CABG surgery

Renal function

Time frame: 72 hours post CABG

Data from ClinicalTrials.gov

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