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

Primary Purpose

Coronary Artery Stenosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
St Thomas
Custodiol
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Stenosis focused on measuring Coronary Artery Bypass, Coronary Artery Surgery, Coronary Artery Bypass Graft, Coronary Revascularization, Cardiac microdialysis, Custodiol, St Thomas, Cardioplegic solutions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Saint-Eienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

St Thomas

Custodiol

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Anoxic variations 24h
Interstitial lactate and pyruvate concentrations, lactate/pyruvate ratio, and glycerol concentration (glycerol is a marker of cell membrane damage),
Drug consumption
Inotropic drug consumption (dobutamin, noradrenalin, adrenalin) during the first 72 hours following declamping

Full Information

First Posted
July 20, 2011
Last Updated
March 16, 2012
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Jazz Pharmaceuticals, Association AIRE (FR)
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1. Study Identification

Unique Protocol Identification Number
NCT01401140
Brief Title
Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis
Acronym
Cardioplégie
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Jazz Pharmaceuticals, Association AIRE (FR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
Coronary Artery Bypass, Coronary Artery Surgery, Coronary Artery Bypass Graft, Coronary Revascularization, Cardiac microdialysis, Custodiol, St Thomas, Cardioplegic solutions

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
St Thomas
Arm Type
Active Comparator
Arm Title
Custodiol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
St Thomas
Other Intervention Name(s)
St Thomas solution or SLF 103 (Aguettant)
Intervention Description
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
Intervention Name(s)
Custodiol
Other Intervention Name(s)
Custodiol (Eusa Pharma)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lactate concentrations per-operatory
Description
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)
Time Frame
Every 10 minutes between the beginning of surgery, and declamping (per-operatory)
Secondary Outcome Measure Information:
Title
Anoxic variations 24h
Description
Interstitial lactate and pyruvate concentrations, lactate/pyruvate ratio, and glycerol concentration (glycerol is a marker of cell membrane damage),
Time Frame
Every hours after end of surgery and until the 24th hour following declamping.
Title
Drug consumption
Description
Inotropic drug consumption (dobutamin, noradrenalin, adrenalin) during the first 72 hours following declamping
Time Frame
At 72 hours after declamping

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco VOLA, MD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Eienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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