Clinical trial NCT02442050: Del Nido Cardioplegia Randomized Trial
Official title: The Use of Del Nido Cardioplegia in Adult Cardiac Surgery: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Perfusion
Keywords: CABG
valve surgery
cardioplegia
heart surgery
cardiac surgery
Cardio-Pulmonary Bypass
myocardial arrest
coronary artery bypass graft
CPB
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 99
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Return to spontaneous sinus rhythm
timeFrame: Collected from beginning of surgery until transfer of patient out of the operating room.
measure: Defibrillation requirement
timeFrame: Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.
measure: Hemodynamic instability
timeFrame: Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.
measure: Change in blood troponin levels
timeFrame: Measured once immediately before surgery, then at 3 time-points post surgery (at 2, 12, 24 hours post-surgery).
measure: Inotropic requirement
timeFrame: Assessed from beginning of surgery until patient is discharged from the hospital, an expected average of 9 days.
Secondary outcomes:
measure: Post-Operative Clinical Outcomes
timeFrame: Assessed from beginning of surgery until patient discharge from hospital, an expected average of 9 days, or up to 30 days after surgery for select outcomes (see below).
measure: Ejection fraction at termination of CPB
timeFrame: During surgical procedure at the termination of CPB
measure: Total duration of CPB
timeFrame: Measured during surgery from start to end of CPB
measure: Total aortic cross clamp duration
timeFrame: Measured during surgery from start to end of aortic cross clamp
measure: Amount of cardioplegia solution
timeFrame: Measured from start to end of surgery
measure: Cardioplegia costs
timeFrame: Measured from start to end of surgery
measure: Total expense of surgical stay
timeFrame: Measured from patient admission to hospital until discharge from hospital, an expected average of 9 days.
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: CVTSA
state: Virginia
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
Study officials:
affiliation: Inova Fairfax Hospital
name: Niv Ad, MD
role: PRINCIPAL_INVESTIGATOR
References: