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

NCT01401140 | Completed Phase 3

• 2 other identifiers: 09080332009-A00506-51
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Stenosis

Keywords

Coronary Artery Bypass; Coronary Artery Surgery; Coronary Artery Bypass Graft; Coronary Revascularization; Cardiac microdialysis; Custodiol; St Thomas; Cardioplegic solutions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anoxic variations 24h

  Every hours after end of surgery and until the 24th hour following declamping.

• Drug consumption

  At 72 hours after declamping

Study Arms (2)

St Thomas

ACTIVE COMPARATOR

Drug: St Thomas

Custodiol

EXPERIMENTAL

Drug: Custodiol

Interventions

St Thomas 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.

Also known as: St Thomas solution or SLF 103 (Aguettant)

St Thomas

Custodiol 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.

Also known as: Custodiol (Eusa Pharma)

Custodiol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Jazz Pharmaceuticals: collaborator
• Association AIRE (FR): collaborator

Study Sites (1)

CHU de Saint-Eienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Coronary Stenosis

Interventions

St. Thomas' Hospital cardioplegic solution

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Marco VOLA, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 25, 2011
• Study Start: June 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

FR (1)