Ischaemia-r�perfusion During the Coronary Surgery With Beating Heart

Condition(s) targeted: Ischaemia-reperfusion Injury

Intervention: Placebo (Drug); Diltiazem (Drug); Acetylcystein (Drug); diltiazem and acetylcystein (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University Hospital, Strasbourg, France

Official(s) and/or principal investigator(s):
Annick Steib, MD, PhD, Study Director, Affiliation: Strasbourg University Hospital, France

Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.

Official title: Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine

Minimum age: 60 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age included between 60 and 80 years

Exclusion Criteria:

- Age < 60 or > 80 years

- Pregnancy

- The allergy in used medicines (N-acétylcystéine, Diltiazem)

- Presence of a pathology valvulaire associated

- Urgency

- Unstable angor

- Bypass as a matter of urgency

- Recours peropératoire to a CEC

- FE < 0,40

- BAV of the 2nd and 3rd not sailed degree

- fibrillation or flutter little finger.

Department of Anaesthesiology, Strasbourg 67091, France

Starting date: June 2002
Last updated: January 16, 2013