Randomized Multicentric Trial to Compare Efficacy and Security of Bucberg vs Del Nido Cardioplegic Solutions in Isolated Aortic Valve Replacement.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 286
- Locations
- 2
- Primary Endpoint
- CK
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Bukcberg
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.
Intervention: Buckberg (Drug)
Del 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.
Intervention: Del Nido (Drug)
Outcomes
Primary Outcomes
CK
Time Frame: 5 days
CK blood levels
Mortality
Time Frame: 30 days
All cause mortality
Troponin T
Time Frame: 5 days
Troponin T blood levels
Secondary Outcomes
No secondary outcomes reported