Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)

Summary

Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular mechanisms leading to these effects are yet not fully understood. The purpose of the present study is to validate previous studies and gather further evidence for RIPC during CABG with blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.

Conditions

• Myocardial Injury

Interventions

PROCEDURE

Remote ischemic preconditioning (RIPC)

3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion. The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. In the CABG-arms, during extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.

PROCEDURE

Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol

The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia 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.

PROCEDURE

Off-pump Coronary artery bypass surgery without remote ischemic preconditioning

The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required.

Sponsors & Collaborators

• University Hospital, Essen

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  lead OTHER

Principal Investigators

• Payam Akhyari, MD · Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany

• Alexander Albert, MD · Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany

• Artur Lichtenberg, MD · Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany

• Gerd Heusch, MD, PhD · nst. of Pathophysiology, University Duisburg-Essen, University Hospital Essen, Essen, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-06-30

Completion

2015-12-31

Countries

• Germany

Study Locations