Cardiac Surgical Procedures
Conditions
Brief summary
The study compares safety and efficacy of the Del Nido cardioplegic solution, comparing it with the Buckberg cardioplegic solution in single aortic valve replacement procedures. Half the patients will receive the Del Nido solutions while the other half will receive the Buckberg solution.
Interventions
DRUGDel Nido
Del Nido cardioplegic solution administered in a single dose at 15-20mg/Kg with a maximum dose of 1L of solution, administered antegrade or retrograde. In those patients in wich the crossclamping time exceed 90 to 120 minutes a manteinance dose of 500ml will be administered.
DRUGBuckberg
Buckberg cardioplegical solution administered antegrade and/or retrograde at 1-2ml/Kg for cardiac arrest induction. Arrest manteinance with antegrade and/or retrograde administration at 1-2ml/Kg every 15 to 20 minutes. Reperfusion dose with antegrade or retrograde administration at 15-20 ml/Kg before removing the aortic crossclamp.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years old * Patients listed for elective aortic valve replacement * Patients that have signed informed consent
Exclusion criteria
* Emergent surgery * Patients that do not accept blood transfusion * Patients with previous cardiac surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | All cause mortality |
| Troponin T | 5 days | Troponin T blood levels |
| CK | 5 days | CK blood levels |
Countries
Spain
Outcome results
None listed