Effect of Preliminary Administration of Cyclosporine (Sandimmun ®) on Different Markers of Cardiac Ischaemia Induced by Cardiopulmonary Bypass

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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