Clinical trial NCT04094168: Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery
Official title: Clinical Outcomes of Del Nido Cardioplegia in Adult Cardiac Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Keywords: Del Nido Cardioplegia
Cardioplegia
Adult Cardiac Surgery
Myocardial protection
Heart surgery
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Blood troponin levels.
timeFrame: Up to 48 hours
measure: Acute cardiovascular event.
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Ventricular fibrillation after aortic cross-clamp removal.
timeFrame: Intraoperative.
measure: Defibrillation requirement.
timeFrame: Intraoperative.
measure: Cardioplegia delivery.
timeFrame: Intraoperative.
measure: Cardiopulmonary bypass time (CBP).
timeFrame: Intraoperative.
measure: Aortic cross-clamp time
timeFrame: Intraoperative.
measure: Return to cardiopulmonary bypass.
timeFrame: Intraoperative
measure: Intraoperative packed red blood cells transfusion.
timeFrame: Intraoperative
measure: Intraoperative maximal blood glucose concentration.
timeFrame: Intraoperative
measure: Postoperative atrial fibrillation.
timeFrame: Up to 2 weeks.
measure: Reoperation.
timeFrame: Up to 24 hours.
measure: Inotropic or vasopressor support in intensive care unit.
timeFrame: At admission in intensive care unit, 24, 48 hours.
measure: Duration of inotropic support after cardiopulmonary bypass.
timeFrame: Up to 2 weeks.
measure: Time to extubation.
timeFrame: Up to 2 weeks.
measure: Acute renal failure.
timeFrame: Up to 2 weeks.
measure: Ischemic stroke.
timeFrame: Up to 2 weeks.
measure: Delirium.
timeFrame: Up to 2 weeks.
measure: Postoperative packed red blood cells transfusion.
timeFrame: Up to 1 week.
measure: Length of stay in intensive care unit
timeFrame: through study completion, an average 1 month.
measure: Length of stay in hospital
timeFrame: through study completion, an average 6 months.
measure: Postoperative ventricular ejection fraction change.
timeFrame: through study completion, an average 6 months.
measure: Mortality.
timeFrame: through study completion, an average 6 months.
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Puerta de Hierro Hospital
state: Madrid
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.