Heart; Surgery, Heart, Functional Disturbance as Result Clinical Trial
Official title:
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.
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).
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