Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

NCT01771978 | Unknown Phase 3

• 1 other identifier: 2276
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ischaemia-reperfusion injury; cardiac surgery; oxidative stress markers; troponin; diltiazem; acetylcystein

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Arm1: control group

PLACEBO COMPARATOR

Received 250 ml of a 5% dextrose solution as placebo drug

Drug: Placebo

Arm 2: diltiazem group

EXPERIMENTAL

Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution

Drug: Diltiazem

Arm 3: acetylcystein group

EXPERIMENTAL

Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution

Drug: Acetylcystein

Arm 4: diltiazem and acetylcystein group

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

Drug: diltiazem and acetylcystein

Interventions

Placebo DRUG

Received 250 ml of a 5% dextrose solution as placebo

Also known as: placebo group

Arm1: control group

Diltiazem DRUG

Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution

Also known as: Diltiazem group

Arm 2: diltiazem group

Acetylcystein DRUG

Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution

Also known as: Acetylcystein group

Arm 3: acetylcystein group

diltiazem and acetylcystein DRUG

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

Also known as: Combined diltiazem and acetylcystein drug group

Arm 4: diltiazem and acetylcystein group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age included between 60 and 80 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Department of Anaesthesiology

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Diltiazem

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Annick Steib, MD, PhD

  Strasbourg University Hospital, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 18, 2013
• Study Start: June 1, 2002
• Primary Completion: February 1, 2008
• Last Updated: January 18, 2013

Record last verified: 2008-02

Locations

FR (1)