NCT01771978

Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ischaemia-reperfusion Injury

Interventions

Type	Name	Description
DRUG	Placebo	Received 250 ml of a 5% dextrose solution as placebo
DRUG	Diltiazem	Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
DRUG	Acetylcystein	Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
DRUG	diltiazem and acetylcystein	Received a combination of drug :diltiazem and acetylcystein * bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution * 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution

Timeline

• Start date: 2002-06-01
• Primary completion: 2008-02-01
• First posted: 2013-01-18
• Last updated: 2013-01-18

Locations

1 site across 1 country: France