Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)
NCT ID: NCT01608984
Last Updated: 2013-07-16
Study Results
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Basic Information
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UNKNOWN
PHASE1
100 participants
INTERVENTIONAL
2012-05-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RIPC-CABG
Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery with blood cardioplegia for cardiac arrest (CABG) 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 to 10 Minutes after aortic unclamping during reperfusion of the myocardium. Blood samples are taken up to 72 hours postoperatively.
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.
Control-CABG
Control group: Coronary artery bypass grafting without RIPC protocol
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.
RIPC-OPCAB
Remote ischemic preconditioning (RIPC) protocol before Off-pump coronary artery bypass surgery (OPCAB) 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 first coronary artery incision and 5 to 10 Minutes after completion of the coronary anastomoses. Blood samples are taken up to 72 hours postoperatively.
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.
Control-OPCAB
Control group: Off-pump Coronary artery bypass surgery without RIPC protocol
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indication for surgical coronary revascularisation
* Written informed consent
* Age ≥ 18 years
Exclusion Criteria
* Instable angina/acute coronary syndrome
* Emergency surgery
* Recent myocardial infarction within 7 days prior to surgery
* Recent major infection/sepsis within 7 days prior to surgery
* Significant hepatic, renal oder pulmonary disease
* Other concomitant surgical procedures
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Essen
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Principal Investigators
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Payam Akhyari, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Alexander Albert, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Artur Lichtenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Gerd Heusch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
nst. of Pathophysiology, University Duisburg-Essen, University Hospital Essen, Essen, Germany
Locations
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Dept. Cardiovascular Surgery, University Hospital, Heinrich Heine University
Düsseldorf, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Hausenloy DJ, Erik Botker H, Condorelli G, Ferdinandy P, Garcia-Dorado D, Heusch G, Lecour S, van Laake LW, Madonna R, Ruiz-Meana M, Schulz R, Sluijter JP, Yellon DM, Ovize M. Translating cardioprotection for patient benefit: position paper from the Working Group of Cellular Biology of the Heart of the European Society of Cardiology. Cardiovasc Res. 2013 Apr 1;98(1):7-27. doi: 10.1093/cvr/cvt004. Epub 2013 Jan 19.
Heusch G, Musiolik J, Kottenberg E, Peters J, Jakob H, Thielmann M. STAT5 activation and cardioprotection by remote ischemic preconditioning in humans: short communication. Circ Res. 2012 Jan 6;110(1):111-5. doi: 10.1161/CIRCRESAHA.111.259556. Epub 2011 Nov 23.
Other Identifiers
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RIPCON-12
Identifier Type: -
Identifier Source: org_study_id
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