Del Nido Cardioplegia Randomized Trial
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Details and patient eligibility
About
The use of a modified depolarizing cardioplegia solution in adult cardiac surgery would allow for prolonged re-dosing intervals while providing equivalent myocardial protection. The use of del Nido solution has been used extensively in congenital heart surgery for over 25 years. The primary objective is to determine whether expanding this technique to adult cardiac surgery will confer significant benefits in both surgical workflow and patient clinical outcome. The investigators hypotheses with regard to the del Nido solution will demonstrate (1) a non-inferior delivery to the current blood-based cardioplegia strategy in functional recovery or clinical outcome, and (2) superior delivery to the current blood-based cardioplegia strategy in cost analyses.
Full description
This prospective randomized controlled trial is designed for adult patients between the ages of 19-79 presenting for isolated CABG or single valve surgery, with or without CABG, requiring the use of Cardio-Pulmonary Bypass (CPB). Patients with previous cardiac surgery or requiring mechanical and pharmacologic support will be excluded from the study.
Subjects randomized to the intervention group will receive del Nido cardioplegia solution during the aortic cross clamp period. The control group will receive whole-blood cardioplegia according to the Inova Fairfax Adult Cardioplegia protocol. Primary outcomes include clinical indicators for myocardial preservation such as serum troponin levels and the return of spontaneous rhythm. Surrogate primary endpoints for myocardial protection include the requirement for inotropic support and the need for defibrillation after coronary reperfusion. Secondary endpoints include post-operative clinical outcomes, duration of the aortic cross clamp period, and total expenses incurred during the patient length of stay.
The investigators will conduct non-inferiority analyses to examine the effect of cardioplegia treatment arm on clinical outcomes and complications. Analyses of binary outcomes will use a 5% non-inferiority margin and analyses of continuous outcomes will use a 10% non-inferiority margin.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Subjects able to receive and provide informed consent
- Elective surgical procedures requiring CPB and myocardial arrest
- Isolated coronary artery bypass graft (CABG) surgery or single valve surgery, with or without CABG
Exclusion criteria
- Previous cardiac surgery
- Patients with preoperative inotropic pharmacological support
- Patients on preoperative mechanical circulatory support
- Patients with an implanted pacemaker or implantable cardioverter defibrillator
- Patients with non-isolated CABG or other non-CABG procedures with single valve surgery
Trial design
Primary purpose
Allocation
Interventional model
Masking
99 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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