Del Nido Cardioplegia Randomized Trial

Cardiac Perfusion Clinical Trial

Official title:

The Use of Del Nido Cardioplegia in Adult Cardiac Surgery: A Prospective Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02442050
• Other study ID #: #14-1653
• Status: Terminated
• Phase: N/A
• Start date: January 2015
• Est. completion date: April 4, 2017

Study information

• Verified date: December 2021
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Perfusion

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	CVTSA	Falls Church	Virginia
United States	Inova Heart and Vascular Institute	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to spontaneous sinus rhythm	Return to spontaneous sinus rhythm measured as yes or no	Collected from beginning of surgery until transfer of patient out of the operating room.
Primary	Defibrillation requirement	• Defibrillation requirement will be measured as: Defibrillation needed after coronary reperfusion (Y/N); Number of defibrillations required	Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.
Primary	Hemodynamic instability	Measures as return to cardiopulmonary bypass (CPB) due to hemodynamic instability (Y/N)	Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.
Primary	Change in blood troponin levels	• Blood troponin levels measured at: Baseline prior to surgery; 2 hours after termination of cardiopulmonary bypass; 12 hours after admission to the Cardiac Intensive Care Unit; 24 hours after admission to the Cardiac Intensive Care Unit	Measured once immediately before surgery, then at 3 time-points post surgery (at 2, 12, 24 hours post-surgery).
Primary	Inotropic requirement	• Inotropic requirements will be measures as: Inotropic pharmacologic support (Y/N); Duration of inotropic support after cardiopulmonary bypass measured in hours	Assessed from beginning of surgery until patient is discharged from the hospital, an expected average of 9 days.
Secondary	Post-Operative Clinical Outcomes	Postoperative clinical outcomes, as defined by the Society of Thoracic Surgeons Adult Cardiac Surgical Database; • Operative mortality and readmissions are assessed up to 30 days after surgery	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).
Secondary	Ejection fraction at termination of CPB	Calculated ejection fraction at termination of Cardiopulmonary bypass (via TEE- in percentage)	During surgical procedure at the termination of CPB
Secondary	Total duration of CPB	Cardiopulmonary bypass duration measured as the total number of minutes.	Measured during surgery from start to end of CPB
Secondary	Total aortic cross clamp duration	Aortic cross clamp duration measured as the total number of minutes.	Measured during surgery from start to end of aortic cross clamp
Secondary	Amount of cardioplegia solution	Total amount of cardioplegia solution administered measured in mL	Measured from start to end of surgery
Secondary	Cardioplegia costs	Cardioplegia costs (US dollars) including: Solution preparation; Disposables; Delivery system and associated tools	Measured from start to end of surgery
Secondary	Total expense of surgical stay	Total expenses incurred during entire patient length of hospital stay (US dollars)	Measured from patient admission to hospital until discharge from hospital, an expected average of 9 days.