Del Nido Cardioplegia Randomized Trial

NCT ID: NCT02442050

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-04-04

Brief Summary

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.

Detailed 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.

Conditions

Cardiac Perfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

del Nido solution

Administering of cardioplegia using del Nido solution in eligible patients.

Group Type: EXPERIMENTAL

del Nido solution

Intervention Type: OTHER

1.0-liter of del Nido Cardioplegia after the aortic cross-clamp is applied to the ascending aorta. Delivery of del Nido solution will be administered in a 1:4 ratio of blood:crystalloid at a temperature of 6-10 degrees centigrade.

Blood-based cardioplegia

Administering of cardioplegia using current standard of care blood-based cardioplegia protocol.

Group Type: ACTIVE_COMPARATOR

Blood-based cardioplegia

Intervention Type: OTHER

An induction dose of whole blood cardioplegia ranging from 1.0-2.0 liters of solution will be given, with subsequent doses of cardioplegia every 20 minutes.

Interventions

del Nido solution

1.0-liter of del Nido Cardioplegia after the aortic cross-clamp is applied to the ascending aorta. Delivery of del Nido solution will be administered in a 1:4 ratio of blood:crystalloid at a temperature of 6-10 degrees centigrade.

Intervention Type: OTHER

Blood-based cardioplegia

An induction dose of whole blood cardioplegia ranging from 1.0-2.0 liters of solution will be given, with subsequent doses of cardioplegia every 20 minutes.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niv Ad, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Fairfax Hospital

Locations

CVTSA

Falls Church, Virginia, United States

Inova Heart and Vascular Institute

Falls Church, Virginia, United States

Countries

United States

Other Identifiers

#14-1653

Identifier Type: -

Identifier Source: org_study_id