Buckberg vs Del Nido in Isolated Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-16

Study Completion Date

2023-08-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Bukcberg

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.

Group Type ACTIVE_COMPARATOR

Buckberg

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Del Nido

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG