Comparative study of two types of cardioplegia during cardiac surgery in the adult patient

Phase 1

• Conditions: Cardiac surgery; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-005144-14-ES
• Lead Sponsor: Dr. Forteza Gil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

• Patients over 18 years of age.
• Patients undergoing scheduled surgery under extracorporeal circulation.
• Patients who, after receiving information about the study, authorize their participation in writing.
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 474
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 474

Exclusion Criteria

• Patients under 18 years of age.
• Patients who do not consent to participate in the study.
• Documented allergy to amide-type local anesthetics.
• Emergent surgery. It includes:
--- Surgery: cardiac transplant, aortic dissection, endocarditis, shock code.
--- Regardless of the type of surgical intervention, all those unstable patients who require pharmacological inotropic support, mechanical support (BCIAO, ECMO) or preoperative intubation.
• Patients undergoing surgery scheduled under a minimally invasive Heart Port procedure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified