Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis

Phase 3

Completed

• Conditions: Coronary Artery Stenosis
• Interventions: Drug: Custodiol; Drug: St Thomas

• Registration Number: NCT01401140
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custodiol	Custodiol	-
St Thomas	St Thomas	-

Primary Outcome Measures

Name	Time	Method
Lactate concentrations per-operatory	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 Outcome Measures

Name	Time	Method
Anoxic variations 24h	Every hours after end of surgery and until the 24th hour following declamping.	Interstitial lactate and pyruvate concentrations, lactate/pyruvate ratio, and glycerol concentration (glycerol is a marker of cell membrane damage),
Drug consumption	At 72 hours after declamping	Inotropic drug consumption (dobutamin, noradrenalin, adrenalin) during the first 72 hours following declamping

Trial Locations

Locations (1)

CHU de Saint-Eienne; 🇫🇷 Saint-etienne, France