Buckberg vs Del Nido in Isolated Aortic Valve Replacement

NCT04259515 | Completed Phase 4 DMC

• 2 other identifiers: IIBSP-CAR-2018-712018-002701-59
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (3)

• Mortality

  All cause mortality

  30 days

• Troponin T

  Troponin T blood levels

  5 days

• CK

  CK blood levels

  5 days

Study Arms (2)

Bukcberg

ACTIVE COMPARATOR

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.

Drug: Buckberg

Del Nido

EXPERIMENTAL

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: Del Nido

Interventions

Del Nido DRUG

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.

Del Nido

Buckberg DRUG

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.

Bukcberg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years old
• Patients listed for elective aortic valve replacement
• Patients that have signed informed consent

You may not qualify if:

• Emergent surgery
• Patients that do not accept blood transfusion
• Patients with previous cardiac surgery

Sponsors & Collaborators

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

Study Sites (2)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Interventions

Del Nido cardioplegia solution

Study Officials

• Manel Tauron, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 6, 2020
• Study Start: July 16, 2019
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)