Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis
Overview
- Phase
- Phase 3
- Intervention
- St Thomas
- Conditions
- Coronary Artery Stenosis
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Lactate concentrations per-operatory
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.
High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.
Detailed Description
Myocardial microdialysis is the state-of-the-art technique for evaluating the protective effects of cardioplegic solutions; it enables physicians to monitor oxidation-reduction muscle metabolism during an ongoing operation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient was referred to the Cardiovascular Surgery Unit for surgical coronary revascularization
- •Patient has anterior interventricular stenosis
- •Patient signed the informed consent form
- •Patient is covered by health insurance
Exclusion Criteria
- •Patients with beating heart surgery indication (no extracorporeal circulation required)
- •Emergency surgery and patients who suffered myocardial infarction less than a week before surgery
- •Iterative surgery
Arms & Interventions
St Thomas
Intervention: St Thomas
Custodiol
Intervention: Custodiol
Outcomes
Primary Outcomes
Lactate concentrations per-operatory
Time Frame: Every 10 minutes between the beginning of surgery, and declamping (per-operatory)
Mean interstitial lactate concentrations (lactate peak and lactate/pyruvate ratio) observed between the beginning of surgery, and declamping in each patient group (St Thomas cardioplegia group vs Custodiol cardioplegia group)
Secondary Outcomes
- Anoxic variations 24h(Every hours after end of surgery and until the 24th hour following declamping.)
- Drug consumption(At 72 hours after declamping)