Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest
Overview
- Phase
- Phase 2
- Intervention
- RIPC
- Conditions
- Myocardial Injury
- Sponsor
- University Hospital, Essen
- Enrollment
- 1204
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Matthias Thielmann
Matthias Thielman, MD, PhD
University Hospital, Essen
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: 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.
Intervention: isoflurane+sufentanil anesthesia
Control
Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
Intervention: Control
Control
Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
Intervention: isoflurane+sufentanil anesthesia
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(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)