Overview

This trial is active, not recruiting.

Condition ischaemia-reperfusion injury
Treatments placebo, diltiazem, acetylcystein, diltiazem and acetylcystein
Phase phase 3
Sponsor University Hospital, Strasbourg, France
Start date June 2002
End date February 2008
Trial size 120 participants
Trial identifier NCT01771978, 2276

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Placebo Comparator)
Received 250 ml of a 5% dextrose solution as placebo drug
placebo placebo group
Received 250 ml of a 5% dextrose solution as placebo
(Experimental)
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
diltiazem Diltiazem group
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
(Experimental)
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
acetylcystein Acetylcystein group
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
(Experimental)
Received a combination of drug : bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution and 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution
diltiazem and acetylcystein Combined diltiazem and acetylcystein drug group
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

Primary Outcomes

Measure
Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine
time frame: during ischaemia-reperfusion

Eligibility Criteria

Male or female participants from 60 years up to 80 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University Hospital, Strasbourg, France.