Cardiac PerfusionNCT02442050
Del Nido Cardioplegia Randomized Trial
A study testing del Nido solution and Blood-based cardioplegia in people with Cardiac Perfusion, run by Inova Health Care Services at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Cardiac Perfusion
- What is being tested?
- del Nido solution and Blood-based cardioplegia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to 4 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CVTSA
Falls Church, Virginia, 22042
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
About this study
Official title: The Use of Del Nido Cardioplegia in Adult Cardiac Surgery: A Prospective Randomized Trial
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.
Read the 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
- Being tested
- del Nido solution, Blood-based cardioplegia
- Keywords
- CABG, valve surgery, cardioplegia, heart surgery, cardiac surgery, Cardio-Pulmonary Bypass, myocardial arrest, coronary artery bypass graft, CPB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
del Nido solutionOther
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 cardioplegiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| del Nido solution | Experimental | Administering of cardioplegia using del Nido solution in eligible patients. Receives: Other: del Nido solution |
| Blood-based cardioplegia | Active comparator | Administering of cardioplegia using current standard of care blood-based cardioplegia protocol. Receives: Other: Blood-based cardioplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to spontaneous sinus rhythm
Return to spontaneous sinus rhythm measured as yes or no
Measured: Collected from beginning of surgery until transfer of patient out of the operating room.
Defibrillation requirement
- Defibrillation requirement will be measured as:
- Defibrillation needed after coronary reperfusion (Y/N)
- Number of defibrillations required
Measured: 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)
Measured: 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:
- 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: 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:
- Inotropic pharmacologic support (Y/N)
- Duration of inotropic support after cardiopulmonary bypass measured in hours
Measured: Assessed from beginning of surgery until patient is discharged from the hospital, an expected average of 9 days.
Secondary outcomes (7)
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
Measured: 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).
Ejection fraction at termination of CPB
Calculated ejection fraction at termination of Cardiopulmonary bypass (via TEE- in percentage)
Measured: During surgical procedure at the termination of CPB
Total duration of CPB
Cardiopulmonary bypass duration measured as the total number of minutes.
Measured: 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: 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: Measured from start to end of surgery
Cardioplegia costs
Cardioplegia costs (US dollars) including:
- Solution preparation
- Disposables
- Delivery system and associated tools
Measured: 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: Measured from patient admission to hospital until discharge from hospital, an expected average of 9 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2015
- Primary completion4 Apr 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PerfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niv Ad, MD, Principal investigator, Inova Fairfax Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442050
- Sponsor's protocol ID
- #14-1653
- Status last verified
- Dec 2021
- First submitted
- 30 Mar 2015
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Del Nido Cardioplegia in Adult Cardiac Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02442050
- Acronym / sponsor ID
- #14-1653
- Conditions
- Cardiac Perfusion
- Keywords
- CABG, valve surgery, cardioplegia, heart surgery, cardiac surgery, Cardio-Pulmonary Bypass, myocardial arrest, coronary artery bypass graft
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| del Nido solution | Experimental | Other: del Nido solutionAdministering of cardioplegia using del Nido solution in eligible patients. |
| Blood-based cardioplegia | Active comparator | Other: Blood-based cardioplegiaAdministering of cardioplegia using current standard of care blood-based cardioplegia protocol. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| del Nido solution1.0-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. | Other | del Nido solution |
| Blood-based cardioplegiaAn 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. | Other | Blood-based cardioplegia |
Primary outcome
Return to spontaneous sinus rhythm
Time frame: Collected from beginning of surgery until transfer of patient out of the operating room.
Return to spontaneous sinus rhythm measured as yes or no
Defibrillation requirement
Time frame: Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.
• Defibrillation requirement will be measured as: * Defibrillation needed after coronary reperfusion (Y/N) * Number of defibrillations required
Hemodynamic instability
Time frame: Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.
Measures as return to cardiopulmonary bypass (CPB) due to hemodynamic instability (Y/N)
Change in blood troponin levels
Time frame: Measured once immediately before surgery, then at 3 time-points post surgery (at 2, 12, 24 hours post-surgery).
• 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
Inotropic requirement
Time frame: Assessed from beginning of surgery until patient is discharged from the hospital, an expected average of 9 days.
• Inotropic requirements will be measures as: * Inotropic pharmacologic support (Y/N) * Duration of inotropic support after cardiopulmonary bypass measured in hours
7 secondary outcomes
Post-Operative Clinical Outcomes
Time frame: 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).
Ejection fraction at termination of CPB
Time frame: During surgical procedure at the termination of CPB
Total duration of CPB
Time frame: Measured during surgery from start to end of CPB
Total aortic cross clamp duration
Time frame: Measured during surgery from start to end of aortic cross clamp
Amount of cardioplegia solution
Time frame: Measured from start to end of surgery
Cardioplegia costs
Time frame: Measured from start to end of surgery
Total expense of surgical stay
Time frame: Measured from patient admission to hospital until discharge from hospital, an expected average of 9 days.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niv Ad, MD principal investigator
Inova Fairfax Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing del Nido solution and Blood-based cardioplegia in people with Cardiac Perfusion, run by Inova Health Care Services at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to spontaneous sinus rhythm (time frame: Collected from beginning of surgery until transfer of patient out of the operating room.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.