Evaluation of clinical impact of the type of cardioplegia used in the patient undergoing major cardiac surgery with extracorporeal circulation. CARDIO-HEART clinical trial.

Phase 4

Not yet recruiting

• Conditions: Cardiovascular surgery

• Registration Number: 2024-511948-42-00
• Lead Sponsor: Hospital Clinico San Carlos

Brief Summary

General objective:

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

Patients over 18 years of age.

Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.

Exclusion Criteria

1. Pregnancy.

2. Aortic arch procedures.

3. Procedures in which hypothermia <28ºC is expected during the intervention.

4. Minimally invasive procedures “Port Access”.

5. Active endocarditis.

6. Emerging procedures.

7. Isolated aortic valve replacements.

8. Decision of the main surgeon not to participate in the study due to other clinical criteria.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) Comparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure in patients administered Custodiol crystalloid cardioplegia and Buckberg hematic cardioplegia 90 days after the intervention.		a) Comparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure in patients administered Custodiol crystalloid cardioplegia and Buckberg hematic cardioplegia 90 days after the intervention.

Secondary Outcome Measures

Name	Time	Method
a) Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.		a) Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.
b) Comparison of 90-day postoperative mortality.		b) Comparison of 90-day postoperative mortality.
c) Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours.		c) Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours.
d) Comparison of AKIN-III acute kidney failure event.		d) Comparison of AKIN-III acute kidney failure event.
e) Comparison of perioperative AMI incidence.		e) Comparison of perioperative AMI incidence.
f) Comparison of major bleeding event or life-threatening or disabling hemorrhage.		f) Comparison of major bleeding event or life-threatening or disabling hemorrhage.
g) Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours.		g) Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours.
h) Comparison of the need for prolonged mechanical ventilation for >24h.		h) Comparison of the need for prolonged mechanical ventilation for >24h.
i) Comparison of type 1 and type 2 neurological complications.		i) Comparison of type 1 and type 2 neurological complications.
j) Comparison of the incidence of postoperative atrial fibrillation.		j) Comparison of the incidence of postoperative atrial fibrillation.
k) Comparison of overall survival at 90 days.		k) Comparison of overall survival at 90 days.

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos

🇪🇸Madrid, Spain

Lourdes Montero Cruces

Site contact

913303000

lourdes.montero@salud.madrid.org