Buckberg vs Del Nido in Isolated Aortic Valve Replacement

Cardiac Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04259515
• Other study ID #: IIBSP-CAR-2018-71
• Secondary ID: 2018-002701-59
• Status: Recruiting
• Phase: Phase 4
• Start date: July 16, 2019
• Est. completion date: July 2022

Study information

• Verified date: February 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Manel Tauron, MD
• Phone: 935565954
• Email: mtauron[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All cause mortality	30 days
Primary	Troponin T	Troponin T blood levels	5 days
Primary	CK	CK blood levels	5 days