Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

Ischaemia-reperfusion Injury Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01771978
• Other study ID #: 2276
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 27, 2012
• Last updated: January 16, 2013
• Start date: June 2002

Study information

• Verified date: February 2008
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ischaemia-reperfusion Injury
• Ischemia
• Reperfusion Injury

Intervention

Drug:
• Placebo
Received 250 ml of a 5% dextrose solution as placebo
• Diltiazem
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
• Acetylcystein
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
• 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

Locations

Country	Name	City	State
France	Department of Anaesthesiology	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine	Choosing as main biological variable rate cTnI cardiospecific, above the threshold of detection (0.3 mcg / L) in 40% of patients operated on a beating heart hoping to reduce this percentage to 10% as a result of treatment with diltiazem and N-acetylcysteine	during ischaemia-reperfusion	No