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

University Hospital Essen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Myocardial Injury

Treatments: Drug: isoflurane+sufentanil anesthesia; Procedure: RIPC; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01406678

WDHZ-TC-0801

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,204 participants in 2 patient groups, including a placebo group

RIPC

Active Comparator group

Description:

Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery 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 after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and 5 and 10 Minutes after aortic unclamping during reperfusion of the myocardium.

Treatment:

Procedure: RIPC

Drug: isoflurane+sufentanil anesthesia

Control

Placebo Comparator group

Description:

Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol

Treatment:

Procedure: Control

Drug: isoflurane+sufentanil anesthesia