Buckberg vs Del Nido in Isolated Aortic Valve Replacement

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgical Procedures

Treatments: Drug: Buckberg; Drug: Del Nido

Study type: Interventional

Funder types: Other

Identifiers

NCT04259515

IIBSP-CAR-2018-71

2018-002701-59 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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286 participants in 2 patient groups

Bukcberg

Active Comparator group

Description:

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.

Treatment:

Drug: Buckberg

Del Nido

Experimental group

Description:

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.

Treatment:

Drug: Del Nido