Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.
Myocardial protection by administering cardioplegia is a fundamental concept during cardiopulmonary bypass in patients undergoing cardiac surgery. It is a multifactorial strategy, in which cardioplegia is the most important. To date, there is no standardized consensus on the use of cardioplegia in different cardiac surgery procedures, and the best strategy continues to be debated given the wide range available. The choice of the type of cardioplegia should be made on an individual basis, taking into account the surgical procedure and clinical context. The need for a single dose of cardioplegia could favor the use of Custodiol crystaloid cardioplegia in complex cardiac surgeries that require longer extracorporeal circulation time. Both cardioplegia are safe and effective and widely used globally; however, the information provided in the literature is limited, with most of the information coming from retrospective studies.The objective of the present study is to demonstrate the non-inferiority of Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation with prolonged aortic clamping times.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buckberg | Active Comparator | Patients who will be administered Buckberg blood cardioplegia. |
|
| Custodiol | Experimental | Patients who will be administered Custodiol crystalloid cardioplegia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custodiol Htk Soln | Drug | Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the composite event | Comparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure | 90 days after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in the incidence of elevation of Troponin | Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure. | 90 days after the intervention |
| Differences in the 90-day mortality rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lourdes Montero Cruces | Contact | 913303000 | lourdes.montero@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Lourdes Montero Cruces | Hospital San Carlos, Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Once the patient is included in the study, they will be assigned an identification number and a treatment group.
Group 1: Patients who will be administered Buckberg blood cardioplegia.
Group 2: Patients who will be administered Custodiol crystalloid cardioplegia. A 1:1 randomization will be carried out by blocks and stratified by weight of the intervention according to the EuroSCORE II:
Not provided
Not provided
Not provided
|
| Buckberg Cardi-Braun | Drug | Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia. |
|
|
Comparison of 90-day postoperative mortality
| 90 days after the intervention |
| Differences in the incidence of low cardiac postoperative output | Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours. | 90 days after the intervention |
| Differences in the incidence of acute kidney failure event | Comparison of AKIN-III acute kidney failure event | 90 days after the intervention |
| Differences in the incidence of acute myocardial infarction | Comparison of perioperative AMI incidence | 90 days after the intervention |
| Differences in the incidence of major bleeding event | Comparison of major bleeding event or life-threatening or disabling hemorrhage. | 90 days after the intervention |
| Differences in the incidence of the need of transfusion | Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours. | 90 days after the intervention |
| Differences in the incidence of prolonged mechanical ventilation | Comparison of the need for prolonged mechanical ventilation for >24h. | 90 days after the intervention |
| Differences in the incidence of neurological complications | Comparison of type 1 and type 2 neurological complications. | 90 days after the intervention |
| Differences in the incidence of postoperative atrial fibrillation. | Comparison of the incidence of postoperative atrial fibrillation. | 90 days after the intervention |
| Differences in the overall survival rate at 90 days. | Comparison of overall survival at 90 days. | 90 days after the intervention |