- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04094168
Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery
Clinical Outcomes of Del Nido Cardioplegia in Adult Cardiac Surgery: a Randomized Controlled Trial
Cardioplegia solutions have been used for myocardial protection in cardiac surgery for decades. Different cardioplegic strategies have been evaluated.
Del Nido cardioplegia was initially used in pediatric patients and has been expanding into adult cardiac centers over the last decade. It can be used as a single dose and it is a reasonable tool do decrease cardioplegic interventions. Recent meta-analysis based on 9 retrospective studies has shown that "clinical outcomes of Del Nido cardioplegia are noninferior to the outcomes of conventional cardioplegia in adult cardiac surgery".
To assess the potencial benefits of Del Nido cardioplegia we performed this clinical trial to evaluate superiority of Del Nido cardioplegia compared to cold blood cardioplegia in terms of myocardial protection and clinical-related outcomes. 474 participants will be randomized either into Del Nido cardioplegia protocol or into the cold blood cardioplegia protocol. Perioperative outcomes will be presented.
Study Overview
Status
Intervention / Treatment
Detailed Description
This clinical trial is performed at Puerta de Hierro Hospital in Spain. The protocol has been approved by institutional ethical committee and Spanish Agency of medicines and medical devices (AEMPS).
The aim of the study is to evaluate superiority of Del Nido cardioplegia solution compared to cold blood cardioplegia solution in terms of myocardial protection and clinical-related outcomes.
According to results in recent meta-analysis, the author estimated a total sample size of 474 participants to give 80 % of power at the 5% significant level.
Participants aged 18 years or older undergoing elective cardiac surgery are randomized 1:1 to receive Del Nido cardioplegia solution (study group) and cold blood cardioplegia solution (control group).
Primary outcome will be assessed by biochemical variables of myocardial injury (troponin T level at inmediate post-op, 3-12 hours, 12-24 hours, 24-48 hours post-op); and clinical variables: "Presence of acute myocardial infarction within 72 hours after surgery", "Prolonged low cardiac output", "Prolonged postoperative vasoplegia" within 48 hours after surgery and/or "Ventricular tachyarrythmias" within 24 hours after surgery.
Secondary outcomes include intraoperative variables of myocardial protection (incidence of ventricular fibrillation, inotropic and vasopressor support at the end of surgical intervention, cardiopulmonary bypass time, aortic cross-clamp time) and postoperative clinical outcomes variables (mechanical ventilation time, incidence of delirium, stroke, acute renal failure, atrial fibrillation, length of stay in intensive care unit, length of stay in hospital and In-hospital mortality).
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jessica García Suárez
- Phone Number: +34660164436
- Email: jessicag.suarez@gmail.com
Study Contact Backup
- Name: Alberto Forteza Gil
- Phone Number: +34636275497
- Email: apforteza@yahoo.es
Study Locations
-
-
Madrid
-
Majadahonda, Madrid, Spain, 28222
- Recruiting
- Puerta De Hierro Hospital
-
Contact:
- Jessica García Suárez
- Phone Number: +34660164436
- Email: jessicag.suarez@gmail.com
-
Contact:
- Alberto Forteza Gil, MD
- Phone Number: +34636275497
- Email: apforteza@yahoo.es
-
Principal Investigator:
- Jessica García Suárez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients age 18 years or older undergoing adult cardiac surgery.
- Elective surgical procedures requiring cardiopulmonary bypass and myocardial arrest.
Exclusion Criteria:
- Emergency surgery.
- Patients on preoperative inotropic support and/or mechanical circulatory support.
- Patient who refuse to participate in the study.
- Lidocaine allergy.
- Port access mitral valve surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Del Nido Cardioplegia solution
1 liter of Del Nido cardioplegia after aortic cross-clamp will be given.
Additional dose will be applied if aortic cross-clamp exceeds 90 minutes or whenever cardiac activity is observed.
|
Del Nido components: Plasmalyte 148 (1000 ml), NaHCO3 8.4% 1M (13 ml), MgSO4 0,5 M (16,5 ml), Mannitol 20% (16,3 ml), KCl 2 M (13 ml), Lidocaine 2% (6,5 ml). Electrolytic composition (l000 ml): Na+ 153 mEq, K+ 31 mEq, Cl - 124 mEq, Mg2+ 19,5 mEq, NaHCO3 13 mEq, Acetate 27 mEq, Sulfate 16,5 mEq, Gluconate 23 mEq. |
Active Comparator: Cold blood Cardioplegia solution
Administering of cardioplegia using current standard of care blood-based cardioplegia protocol.
An induction dose of whole blood cardioplegia will be given at a temperature of 4-8 degrees, with subsequent doses of cardioplegia every 20 minutes or whenever cardiac activity is observed.
|
Cardibraun components: Electrolytic composition (1000 ml): Na+ 185,8 mmol, K+ 24,1 mmol, Cl- 192,8 mmol, Acetate 23 mmol, Fosfate 0,97 mmol, Citrate 6,32 mmol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood troponin levels.
Time Frame: Up to 48 hours
|
Biochemical variables of myocardial injury: Blood troponin levels measured at admission in intensive care unit, 12, 24, 48 hours post-op.
|
Up to 48 hours
|
Acute cardiovascular event.
Time Frame: Up to 72 hours
|
Composite outcome of clinical events "Prolonged low cardiac output", "Prolonged postoperative vasoplegia", "Ventricular tachyarrythmias" and/or "Acute myocardial infarction".
|
Up to 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventricular fibrillation after aortic cross-clamp removal.
Time Frame: Intraoperative.
|
Incidence of ventricular fibrillation after aortic cross-clamp removal (Y/N).
|
Intraoperative.
|
Defibrillation requirement.
Time Frame: Intraoperative.
|
Defibrillation requirement after aortic cross-clamp removal (Y/N).
|
Intraoperative.
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Cardioplegia delivery.
Time Frame: Intraoperative.
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Cardioplegia delivery (antegrade, retrograde, both).
|
Intraoperative.
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Cardiopulmonary bypass time (CBP).
Time Frame: Intraoperative.
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Duration of cardiopulmonary bypass (CBP) (min).
|
Intraoperative.
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Aortic cross-clamp time
Time Frame: Intraoperative.
|
Duration of aortic cross-clamp time (min).
|
Intraoperative.
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Return to cardiopulmonary bypass.
Time Frame: Intraoperative
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Failure to separate from cardiopulmonary bypass (Y/N).
|
Intraoperative
|
Intraoperative packed red blood cells transfusion.
Time Frame: Intraoperative
|
Intraoperative packed red blood cells transfusion (U).
|
Intraoperative
|
Intraoperative maximal blood glucose concentration.
Time Frame: Intraoperative
|
Intraoperative maximal blood glucose concentration (mg/dl).
|
Intraoperative
|
Postoperative atrial fibrillation.
Time Frame: Up to 2 weeks.
|
New-onset atrial fibrillation or hemodynamically unstable atrial fibrillation that requires treatment (Y/N).
|
Up to 2 weeks.
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Reoperation.
Time Frame: Up to 24 hours.
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Reoperation within 24 hours after surgery (Y/N).
|
Up to 24 hours.
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Inotropic or vasopressor support in intensive care unit.
Time Frame: At admission in intensive care unit, 24, 48 hours.
|
Inotropic or vasopressor support in intensive care unit (Y/N).
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At admission in intensive care unit, 24, 48 hours.
|
Duration of inotropic support after cardiopulmonary bypass.
Time Frame: Up to 2 weeks.
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Duration of inotropic support after cardiopulmonary bypass (hours).
|
Up to 2 weeks.
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Time to extubation.
Time Frame: Up to 2 weeks.
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Mechanical ventilation time (min).
|
Up to 2 weeks.
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Acute renal failure.
Time Frame: Up to 2 weeks.
|
Incidence of renal failure (Requirement for postoperative renal replacement therapy) (Y/N).
|
Up to 2 weeks.
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Ischemic stroke.
Time Frame: Up to 2 weeks.
|
Incidence of ischemic stroke (Y/N).
|
Up to 2 weeks.
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Delirium.
Time Frame: Up to 2 weeks.
|
Incidence of delirium (Y/N).
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Up to 2 weeks.
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Postoperative packed red blood cells transfusion.
Time Frame: Up to 1 week.
|
Postoperative packed red blood cells transfusion (U)
|
Up to 1 week.
|
Length of stay in intensive care unit
Time Frame: through study completion, an average 1 month.
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Length of stay in intensive care unit (days).
|
through study completion, an average 1 month.
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Length of stay in hospital
Time Frame: through study completion, an average 6 months.
|
Length of stay in hospital (days).
|
through study completion, an average 6 months.
|
Postoperative ventricular ejection fraction change.
Time Frame: through study completion, an average 6 months.
|
Postoperative ventricular ejection fraction (LVEF) change (Y/N).
|
through study completion, an average 6 months.
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Mortality.
Time Frame: through study completion, an average 6 months.
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Mortality (Y/N).
|
through study completion, an average 6 months.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Buckberg GD, Athanasuleas CL. Cardioplegia: solutions or strategies? Eur J Cardiothorac Surg. 2016 Nov;50(5):787-791. doi: 10.1093/ejcts/ezw228. Epub 2016 Jul 1. No abstract available.
- Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.
- Li Y, Lin H, Zhao Y, Li Z, Liu D, Wu X, Ji B, Gao B. Del Nido Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Systematic Review and Meta-Analysis. ASAIO J. 2018 May/Jun;64(3):360-367. doi: 10.1097/MAT.0000000000000652.
- Lazar HL. del Nido cardioplegia: Passing fad or here to stay? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1009-1010. doi: 10.1016/j.jtcvs.2017.09.126. Epub 2017 Oct 10. No abstract available.
- Tam DY, Fremes SE. Del Nido cardioplegia: A one stop shot for adult cardiac surgery? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1019-1020. doi: 10.1016/j.jtcvs.2017.10.066. Epub 2017 Oct 31. No abstract available.
- Garcia-Suarez J, Garcia Fernandez J, Sanz S, Martinez Lopez D, Reques L, Forteza Gil A. Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17826. doi: 10.2196/17826.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EUDRA CT 2017-005144-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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