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

This study has been completed.
Sponsor:
Collaborators:
EUSA Pharma (US), Inc.
Association AIRE (FR)
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01401140
First received: July 20, 2011
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Drug: St Thomas
Drug: Custodiol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Lactate concentrations per-operatory [ Time Frame: Every 10 minutes between the beginning of surgery, and declamping (per-operatory) ] [ Designated as safety issue: No ]
    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:
  • Anoxic variations 24h [ Time Frame: Every hours after end of surgery and until the 24th hour following declamping. ] [ Designated as safety issue: No ]
    Interstitial lactate and pyruvate concentrations, lactate/pyruvate ratio, and glycerol concentration (glycerol is a marker of cell membrane damage),

  • Drug consumption [ Time Frame: At 72 hours after declamping ] [ Designated as safety issue: No ]
    Inotropic drug consumption (dobutamin, noradrenalin, adrenalin) during the first 72 hours following declamping


Enrollment: 29
Study Start Date: June 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Custodiol (Eusa Pharma)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01401140

Locations
France
CHU de Saint-Eienne
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
EUSA Pharma (US), Inc.
Association AIRE (FR)
Investigators
Principal Investigator: Marco VOLA, MD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01401140     History of Changes
Other Study ID Numbers: 0908033, 2009-A00506-51
Study First Received: July 20, 2011
Last Updated: March 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Coronary Artery Bypass
Coronary Artery Surgery
Coronary Artery Bypass Graft
Coronary Revascularization
Cardiac microdialysis
Custodiol
St Thomas
Cardioplegic solutions

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cardioplegic Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014