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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| del Nido solution | Experimental | Administering of cardioplegia using del Nido solution in eligible patients. |
|
| Blood-based cardioplegia | Active Comparator | Administering of cardioplegia using current standard of care blood-based cardioplegia protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| del Nido solution | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Defibrillation requirement | • Defibrillation requirement will be measured as:
| Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days. |
| 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. |
| Change in blood troponin levels | • Blood troponin levels measured at:
| Measured once immediately before surgery, then at 3 time-points post surgery (at 2, 12, 24 hours post-surgery). |
| Inotropic requirement | • Inotropic requirements will be measures as:
| Assessed from beginning of surgery until patient is discharged from the hospital, an expected average of 9 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niv Ad, MD | Inova Fairfax Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CVTSA | Falls Church | Virginia | 22042 | United States | ||
| Inova Heart and Vascular Institute |
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| ID | Term |
|---|---|
| C000712134 | Del Nido cardioplegia solution |
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| Blood-based cardioplegia | 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. |
|
| 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 |
| Total duration of CPB | Cardiopulmonary bypass duration measured as the total number of minutes. | Measured during surgery from start to end of CPB |
| 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 |
| Amount of cardioplegia solution | Total amount of cardioplegia solution administered measured in mL | Measured from start to end of surgery |
| Cardioplegia costs | Cardioplegia costs (US dollars) including:
| Measured from start to end of surgery |
| 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. |
| Falls Church |
| Virginia |
| 22042 |
| United States |