Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest
- Conditions
- Myocardial Injury
- Interventions
- Procedure: RIPCProcedure: ControlDrug: isoflurane+sufentanil anesthesia
- Registration Number
- NCT01406678
- Lead Sponsor
- University Hospital, Essen
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1204
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIPC RIPC 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. RIPC isoflurane+sufentanil anesthesia 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. Control Control Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol Control isoflurane+sufentanil anesthesia Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
- Primary Outcome Measures
Name Time Method 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). 72 hours postoperatively after CABG surgery
- Secondary Outcome Measures
Name Time Method All-cause mortality 30 days and 1 year and complete follow-up after CABG surgery Myocardial infarction 30 days and 1 year and complete follow-up after CABG surgery Major adverse cardiac and cerebrovascular events (MACCE) at 30 days and 1 year and complete follow-up after CABG surgery Renal function 72 hours post CABG
Trial Locations
- Locations (1)
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, University Duisburg-Essen
🇩🇪Essen, Germany