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

PHASE3CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Coronary Artery Stenosis
Interventions
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.

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.

Trial Locations (1)

42000

CHU de Saint-Eienne, Saint-Etienne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

collaborator

Association AIRE (FR)

UNKNOWN

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER