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

NCT ID: NCT01401140

Last Updated: 2012-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-03-31

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.

Conditions

Coronary Artery Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

St Thomas

Group Type: ACTIVE_COMPARATOR

St Thomas

Intervention Type: DRUG

Once the upper aorta has been clamped, the cardioplegic solution St Thomas will be administered directly into it via an anterograde approach. St Thomas will be infused every 30 minutes at a dosage of 10ml/kg bodyweight (infusion takes about three minutes). If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped.

Custodiol

Group Type: EXPERIMENTAL

Custodiol

Intervention Type: DRUG

Once the upper aorta has been clamped, the cardioplegic solution Custodiol will be administered directly into it via an anterograde approach. Custodiol will be injected in one bolus (20 ml/kg), which takes eight minutes. If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped.

Interventions

St Thomas

Once the upper aorta has been clamped, the cardioplegic solution St Thomas will be administered directly into it via an anterograde approach. St Thomas will be infused every 30 minutes at a dosage of 10ml/kg bodyweight (infusion takes about three minutes). If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped.

Intervention Type: DRUG

Custodiol

Once the upper aorta has been clamped, the cardioplegic solution Custodiol will be administered directly into it via an anterograde approach. Custodiol will be injected in one bolus (20 ml/kg), which takes eight minutes. If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped.

Intervention Type: DRUG

Other Intervention Names

St Thomas solution or SLF 103 (Aguettant); Custodiol (Eusa Pharma)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Association AIRE (FR)

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco VOLA, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Eienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2009-A00506-51

Identifier Type: OTHER

Identifier Source: secondary_id

0908033

Identifier Type: -

Identifier Source: org_study_id