NCT04259515

Buckberg vs Del Nido in Isolated Aortic Valve Replacement

Randomized Multicentric Trial to Compare Efficacy and Security of Bucberg vs Del Nido Cardioplegic Solutions in Isolated Aortic Valve Replacement.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgical Procedures

Interventions

Type	Name	Description
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.
DRUG	Buckberg	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.

Timeline

• Start date: 2019-07-16
• Primary completion: 2023-08-24
• Completion: 2023-08-24
• First posted: 2020-02-06
• Last updated: 2025-06-22

Locations

2 sites across 1 country: Spain