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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 474 (actual)
• Sponsor: JESSICA GARCIA SUAREZ · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart; Surgery, Heart, Functional Disturbance as Result

Interventions

Type	Name	Description
DRUG	DEL NIDO CARDIOPLEGIA	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.
DRUG	COLD BLOOD BASED CARDIOPLEGIA	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.

Timeline

• Start date: 2018-06-15
• Primary completion: 2019-12-15
• Completion: 2020-02-28
• First posted: 2019-09-18
• Last updated: 2025-07-22

Locations

1 site across 1 country: Spain