Study to compare Buckberg cardioplegia and Del Nido cardioplegia in isolated aortic valve replacement surgery

Randomized, open and multi-center clinical trial to compare the efficacy and safety of Buckberg vs Del Nido cardioplegia in isolated aortic valve replacement

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002701-59-ES

Enrollment

286

Registered

2019-05-17

Start date

2019-04-12

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial protection

Interventions

Trade Name: Cardi-Braun Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of legal age (> 18 years) of both sexes Patients who were electively operated on isolated aortic valve replacement in any of the three participating centers. Patients who give informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 286 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Urgent or emergent surgery Patients who refuse transfusion of blood products Patients who do not accept to participate

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of myocardial protection with a cardioplegic solution of the Nido, compared to the Buckberg cardioplegic solution in patients undergoing isolated aortic valve replacement. This efficacy on myocardial protection will be measured by comparing the levels of markers of myocardial injury (CK and Troponin T) between both strategies, as well as in-hospital mortality.;Secondary Objective: To compare other markers of myocardial injury such as LVEF by transthoracic echocardiography, postoperative inotropic need, spontaneous recovery of the post-disinfestation cardiac rhythm or the need for defibrillation. To compare other markers of hemodilution (minimum intraoperative and postoperative hemoglobin and need for transfusion), intra and postoperative glucose and insulin needs, other intraoperative analytical parameters such as intraoperative maximum lactate, aortic clamping times and CPB between both types of cardioplegia.;Primary end point(s): Peak levels of CK in U / L and ultrasensitive Troponin T in ng / L in blood during the postoperative period: the levels of CK and Troponin T in blood will be determined in the first 24 hours postoperatively and later on a daily basis until the peak of both parameters is determined (usually occurs between 2 and 4 days postoperatively). The peak of CK and Troponin T of each of the study subjects will be recorded. Operative mortality: Operative mortality will be considered, mortality within 30 days after surgery, or mortality during admission of the intervention (in patients whose hospital stay exceeds 30 days postoperatively).;Timepoint(s) of evaluation of this end point: 1 - 4 days and 30 days for each primary endpoint respectively	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of myocardial protection with a cardioplegic solution of the Nido, compared to the Buckberg cardioplegic solution in patients undergoing isolated aortic valve replacement. This efficacy on myocardial protection will be measured by comparing the levels of markers of myocardial injury (CK and Troponin T) between both strategies, as well as in-hospital mortality.;Secondary Objective: To compare other markers of myocardial injury such as LVEF by transthoracic echocardiography, postoperative inotropic need, spontaneous recovery of the post-disinfestation cardiac rhythm or the need for defibrillation. To compare other markers of hemodilution (minimum intraoperative and postoperative hemoglobin and need for transfusion), intra and postoperative glucose and insulin needs, other intraoperative analytical parameters such as intraoperative maximum lactate, aortic clamping times and CPB between both types of cardioplegia.;Primary end point(s): Peak levels of CK in U / L and ultrasensitive Troponin T in ng / L in blood during the postoperative period: the levels of CK and Troponin T in blood will be determined in the first 24 hours postoperatively and later on a daily basis until the peak of both parameters is determined (usually occurs between 2 and 4 days postoperatively). The peak of CK and Troponin T of each of the study subjects will be recorded. Operative mortality: Operative mortality will be considered, mortality within 30 days after surgery, or mortality during admission of the intervention (in patients whose hospital stay exceeds 30 days postoperatively).;Timepoint(s) of evaluation of this end point: 1 - 4 days and 30 days for each primary endpoint respectively

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Secondary

Measure	Time frame
Secondary end point(s): Spontaneous recovery of aortic post-release rhythm: it will be recorded during the intraoperative period if there is spontaneous recovery of the heart rhythm when removing the aortic clamp. Need for post-aortic defibrillation: it will be recorded if defibrillation is necessary or not when removing the aortic clamp. Need for inotropes for CEC disconnection: the administration of inotropes for the CEC disconnection will be recorded if necessary or not. If yes, it will also be recorded what inotropes are necessary and in what dose. Minimum intraoperative hemoglobin (in g / L) Need for transfusion of red blood cells Maximum intraoperative glycemia (in mmol / L) Intraoperative insulin needs Insulin needs in the first 48 hours after surgery Maximum intraoperative lactate (in mmol / L) Aortic Impingement Time (minutes) Extracorporeal circulation time (minutes) Left ventricular function by echocardiography at discharge Left ventricular function by echocardiography at 3-6 months postoperatively;Timepoint(s) of evaluation of this end point: 24 hours, 3 months and 6 months	—

Measure

Time frame

Secondary end point(s): Spontaneous recovery of aortic post-release rhythm: it will be recorded during the intraoperative period if there is spontaneous recovery of the heart rhythm when removing the aortic clamp. Need for post-aortic defibrillation: it will be recorded if defibrillation is necessary or not when removing the aortic clamp. Need for inotropes for CEC disconnection: the administration of inotropes for the CEC disconnection will be recorded if necessary or not. If yes, it will also be recorded what inotropes are necessary and in what dose. Minimum intraoperative hemoglobin (in g / L) Need for transfusion of red blood cells Maximum intraoperative glycemia (in mmol / L) Intraoperative insulin needs Insulin needs in the first 48 hours after surgery Maximum intraoperative lactate (in mmol / L) Aortic Impingement Time (minutes) Extracorporeal circulation time (minutes) Left ventricular function by echocardiography at discharge Left ventricular function by echocardiography at 3-6 months postoperatively;Timepoint(s) of evaluation of this end point: 24 hours, 3 months and 6 months

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Countries

Spain

Contacts

Public ContactUICEC Sant Pau

Institut de Recerca Hospital de la Santa Creu i Sant Pau

epenag@santpau.cat+34935537636

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026