Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01401140 | Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis | PHASE3 | COMPLETED | 29 | — | — | Jun 1, 2010 | Mar 1, 2012 | Mar 19, 2012 | 1 | France |
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)
| Arm | Type | Description |
|---|---|---|
| St Thomas | ACTIVE_COMPARATOR | - |
| Custodiol | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
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 he...