Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery

JESSICA GARCIA SUAREZ

Status and phase: Completed; Phase 4

Conditions: Heart; Surgery, Heart, Functional Disturbance as Result

Treatments: Drug: DEL NIDO CARDIOPLEGIA; Drug: COLD BLOOD BASED CARDIOPLEGIA

Study type: Interventional

Funder types: Other

Identifiers

NCT04094168

EUDRA CT 2017-005144-14

Details and patient eligibility

About

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.

Full 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).

Enrollment: 474 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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474 participants in 2 patient groups

Del Nido Cardioplegia solution

Experimental group

Description:

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.

Treatment:

Drug: DEL NIDO CARDIOPLEGIA

Cold blood Cardioplegia solution

Active Comparator group

Description:

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.

Treatment:

Drug: COLD BLOOD BASED CARDIOPLEGIA