Buckberg vs Del Nido in Isolated Aortic Valve Replacement

Phase 4

• Conditions: Cardiac Surgical Procedures
• Interventions: Drug: Buckberg; Drug: Del Nido

• Registration Number: NCT04259515
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-16
• Study First Submitted: 2020-01-21
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-05
• Last Update Submitted: 2020-02-05
• Study First Posted: 2020-02-06
• Last Update Posted: 2020-02-06
• Primary Completion: 2022-03
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bukcberg	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.
Del Nido	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.

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	All cause mortality
Troponin T	5 days	Troponin T blood levels
CK	5 days	CK blood levels

Trial Locations

Locations (3)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain