Del Nido Cardioplegia Randomized Trial

Stopped early · Not applicable

Conditions studied: Cardiac Perfusion

In brief

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.

Key facts

Study ID

NCT02442050

Run by

Inova Health Care Services

People needed

99

Starts

2015-01-01

Expected to finish

2017-04-04

Last updated by the study team

2022-01-12

Who can join

Age: 19 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CVTSA — Falls Church, Virginia, United States
• Inova Heart and Vascular Institute — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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