Clinical trial NCT01401140: Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis
Official title: Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Stenosis
Keywords: Coronary Artery Bypass
Coronary Artery Surgery
Coronary Artery Bypass Graft
Coronary Revascularization
Cardiac microdialysis
Custodiol
St Thomas
Cardioplegic solutions
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Jazz Pharmaceuticals
name: Association AIRE (FR)
First posted: 2011-07-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Lactate concentrations per-operatory
timeFrame: Every 10 minutes between the beginning of surgery, and declamping (per-operatory)
Secondary outcomes:
measure: Anoxic variations 24h
timeFrame: Every hours after end of surgery and until the 24th hour following declamping.
measure: Drug consumption
timeFrame: At 72 hours after declamping
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Eienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Marco VOLA, MD
role: PRINCIPAL_INVESTIGATOR
References: