Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

Study Overview
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Brief Summary
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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
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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

Conditions
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Ischaemia-reperfusion Injury

Intervention / Treatment
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* Drug: Placebo
* Drug: Diltiazem
* Drug: Acetylcystein
* Drug: diltiazem and acetylcystein


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm1: control group<br>Received 250 ml of a 5% dextrose solution as placebo drug | Drug: Placebo<br>* Received 250 ml of a 5% dextrose solution as placebo<br>* Other names: placebo group;|
| Experimental: Arm 2: diltiazem group<br>Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution | Drug: Diltiazem<br>* Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution<br>* Other names: Diltiazem group;|
| Experimental: Arm 3: acetylcystein group<br>Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution | Drug: Acetylcystein<br>* Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution<br>* Other names: Acetylcystein group;|
| Experimental: Arm 4: diltiazem and acetylcystein group<br>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<br>* 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<br>* Other names: Combined diltiazem and acetylcystein drug group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischaemia-reperfusion injury, cardiac surgery, oxidative stress markers, troponin, diltiazem, acetylcystein