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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
474
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.
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.
Puerta de Hierro Hospital
Majadahonda, Madrid, Spain
Blood troponin levels.
Biochemical variables of myocardial injury: Blood troponin levels measured at admission in intensive care unit, 12, 24, 48 hours post-op.
Time frame: Up to 48 hours
Acute cardiovascular event.
Composite outcome of clinical events "Prolonged low cardiac output", "Prolonged postoperative vasoplegia", "Ventricular tachyarrythmias" and/or "Acute myocardial infarction". * Prolonged low cardiac output. Inotropic pharmacologic support more than 48 hours in intensive care unit and/or mechanical circulatory support. * Prolonged postoperative vasoplegia. Vasopressor support more than 48 hours in intensive care unit. * Ventricular tachyarrythmias. Ventricular fibrillation and hemodynamically unstable ventricular tachycardia within 24 hours after surgery. * Acute myocardial infarction within 72 hours after surgery.
Time frame: Up to 72 hours
Ventricular fibrillation after aortic cross-clamp removal.
Incidence of ventricular fibrillation after aortic cross-clamp removal (Y/N).
Time frame: Intraoperative.
Defibrillation requirement.
Defibrillation requirement after aortic cross-clamp removal (Y/N).
Time frame: Intraoperative.
Cardioplegia delivery.
Cardioplegia delivery (antegrade, retrograde, both).
Time frame: Intraoperative.
Cardiopulmonary bypass time (CBP).
Duration of cardiopulmonary bypass (CBP) (min).
Time frame: Intraoperative.
Aortic cross-clamp time
Duration of aortic cross-clamp time (min).
Time frame: Intraoperative.
Return to cardiopulmonary bypass.
Failure to separate from cardiopulmonary bypass (Y/N).
Time frame: Intraoperative
Intraoperative packed red blood cells transfusion.
Intraoperative packed red blood cells transfusion (U).
Time frame: Intraoperative
Intraoperative maximal blood glucose concentration.
Intraoperative maximal blood glucose concentration (mg/dl).
Time frame: Intraoperative
Postoperative atrial fibrillation.
New-onset atrial fibrillation or hemodynamically unstable atrial fibrillation that requires treatment (Y/N).
Time frame: Up to 2 weeks.
Reoperation.
Reoperation within 24 hours after surgery (Y/N).
Time frame: Up to 24 hours.
Inotropic or vasopressor support in intensive care unit.
Inotropic or vasopressor support in intensive care unit (Y/N).
Time frame: At admission in intensive care unit, 24, 48 hours.
Duration of inotropic support after cardiopulmonary bypass.
Duration of inotropic support after cardiopulmonary bypass (hours).
Time frame: Up to 2 weeks.
Time to extubation.
Mechanical ventilation time (min).
Time frame: Up to 2 weeks.
Acute renal failure.
Incidence of renal failure (Requirement for postoperative renal replacement therapy) (Y/N).
Time frame: Up to 2 weeks.
Ischemic stroke.
Incidence of ischemic stroke (Y/N).
Time frame: Up to 2 weeks.
Delirium.
Incidence of delirium (Y/N).
Time frame: Up to 2 weeks.
Postoperative packed red blood cells transfusion.
Postoperative packed red blood cells transfusion (U)
Time frame: Up to 1 week.
Length of stay in intensive care unit
Length of stay in intensive care unit (days).
Time frame: through study completion, an average 1 month.
Length of stay in hospital
Length of stay in hospital (days).
Time frame: through study completion, an average 6 months.
Postoperative ventricular ejection fraction change.
Postoperative ventricular ejection fraction (LVEF) change (Y/N).
Time frame: through study completion, an average 6 months.
Mortality.
Mortality (Y/N).
Time frame: through study completion, an average 6 months.
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