Status:
TERMINATED
Effect of Preliminary Administration of Cyclosporine (Sandimmun ®) on Different Markers of Cardiac Ischaemia Induced by Cardiopulmonary Bypass
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Coronary Artery Bypass Surgery
Cardiopulmonary Bypass
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Observe the effect of preliminary cyclosporine administration on different markers of cardiac ischaemia led by the aortic cross-clamp during coronary artery bypass surgery with Cardiopulmonary bypass.
Detailed Description
The coronary artery bypass surgery, in spite of substantial improvements during the last years, is still associated to a post-operative mortality and morbidity: myocardial infarction, heart failure, c...
Eligibility Criteria
Inclusion
- Patient hospitalized for a coronary artery bypass surgery
- Not urgent surgery
- Left ventricular ejection fraction (LVEF)\> 40 %
- 18 years and older
- patient who have sign the informed consent form
- Affiliation to the French Social Security.
Exclusion
- Beating heart surgery with or without Cardiopulmonary Bypass
- Patient receiving another surgical gesture combined to the CABG
- Myocardial infarction or vascular cerebral attack less than 30 days
- Previous History of cardiac surgery;
- Renal failure (creatinine \> 200 µmol/l)
- Uncontrolled hypertension
- hyperkaliemy;
- hyperuricemy;
- Acute Coronary Syndrome
- Malignant tumor
- Unchecked infection
- Previous intravenous administration of Sandimmun ®;
- allergy to ciclosporin, ethyl alcohol, castor oil or nitrogen
- Pregnant Woman, parturient without contraception, or breast-feeding
- Age \< 18 years
- Patient who have not signed the form of consent;
- Patient Under guardianship or being the object of a legal protective measure
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01002859
Start Date
April 1 2009
End Date
July 1 2011
Last Update
September 5 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of cardiac surgery - University Hospital of Grenoble
Grenoble, France, 38043