Comparison of the protective effect of two cardioplegic solutions Custodiol versus St Thomas on the cardiac metabolism assessed by microdialysis in coronary surgery

• Conditions: Coronary surgery; MedDRA version: 12.0Level: LLTClassification code 10011077Term: Coronary artery bypass; MedDRA version: 12.0Level: LLTClassification code 10011090Term: Coronary artery surgery; MedDRA version: 12.0Level: LLTClassification code 10068176Term: Coronary artery bypass graft; MedDRA version: 12.0Level: LLTClassification code 10011098Term: Coronary bypass; MedDRA version: 12.0Level: LLTClassification code 10054366Term: Coronary revascularization

• Registration Number: EUCTR2009-014690-41-FR
• Lead Sponsor: CHU de Saint-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- aged over 18 years
- referred for Cardiovascular Surgery indicating coronary revascularization surgery
- consent form signed
- social security regimen affiliated
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with an indication of beating-heart surgery
- Emergency surgery and patients with myocardial infarction less than a week before the surgery
- Surgery iterative

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the performance of myocardial protection by cardioplégic solution Custodiol versus St Thomas per procedure by measuring the changes of anoxic myocardial interstitial space by the technique of cardiac microdialysis;Secondary Objective: To compare the effects of myocardial protection of these two cardioplégic solutions (Custodiol and St Thomas) during the first 24 postoperative hours;Primary end point(s): Mean concentrations of interstitial lactate (peak lactate and ratio lactate / pyruvate) observed between the intervention began and when the unclamping in both groups of patients (St Thomas group versus Custodiol group)