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

Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Stenosis
• Intervention / Treatment: Drug: St Thomas; Drug: Custodiol

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Eienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: St Thomas	Drug: 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.; Other Names: St Thomas solution or SLF 103 (Aguettant)
EXPERIMENTAL: Custodiol	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.; Other Names: Custodiol (Eusa Pharma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactate concentrations 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)	Every 10 minutes between the beginning of surgery, and declamping (per-operatory)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Jazz Pharmaceuticals; Association AIRE (FR)
• Investigators: Principal Investigator: Marco VOLA, MD, CHU DE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 22, 2011
• First Posted (ESTIMATE): July 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 19, 2012
• Last Update Submitted That Met QC Criteria: March 16, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Coronary Artery Bypass Graft; Coronary Revascularization; Coronary Artery Bypass; Custodiol; Coronary Artery Surgery; Cardiac microdialysis; St Thomas; Cardioplegic solutions
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: 0908033; 2009-A00506-51 (OTHER: Afssaps)