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Clinical Trials/NCT04094168
NCT04094168CompletedPhase 4

Clinical Outcomes of Del Nido Cardioplegia in Adult Cardiac Surgery: a Randomized Controlled Trial

JESSICA GARCIA SUAREZ1 site in 1 country474 target enrollmentStarted: June 15, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
474
Locations
1
Primary Endpoint
Acute cardiovascular event.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Del Nido Cardioplegia solution

Experimental

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.

Intervention: DEL NIDO CARDIOPLEGIA (Drug)

Cold blood Cardioplegia solution

Active Comparator

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.

Intervention: COLD BLOOD BASED CARDIOPLEGIA (Drug)

Outcomes

Primary Outcomes

Acute cardiovascular event.

Time Frame: Up to 72 hours

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.

Blood troponin levels.

Time Frame: Up to 48 hours

Biochemical variables of myocardial injury: Blood troponin levels measured at admission in intensive care unit, 12, 24, 48 hours post-op.

Secondary Outcomes

  • Ventricular fibrillation after aortic cross-clamp removal.(Intraoperative.)
  • Defibrillation requirement.(Intraoperative.)
  • Cardioplegia delivery.(Intraoperative.)
  • Cardiopulmonary bypass time (CBP).(Intraoperative.)
  • Length of stay in intensive care unit(through study completion, an average 1 month.)
  • Length of stay in hospital(through study completion, an average 6 months.)
  • Postoperative ventricular ejection fraction change.(through study completion, an average 6 months.)
  • Mortality.(through study completion, an average 6 months.)
  • Aortic cross-clamp time(Intraoperative.)
  • Return to cardiopulmonary bypass.(Intraoperative)
  • Intraoperative packed red blood cells transfusion.(Intraoperative)
  • Intraoperative maximal blood glucose concentration.(Intraoperative)
  • Postoperative atrial fibrillation.(Up to 2 weeks.)
  • Reoperation.(Up to 24 hours.)
  • Inotropic or vasopressor support in intensive care unit.(At admission in intensive care unit, 24, 48 hours.)
  • Duration of inotropic support after cardiopulmonary bypass.(Up to 2 weeks.)
  • Time to extubation.(Up to 2 weeks.)
  • Acute renal failure.(Up to 2 weeks.)
  • Ischemic stroke.(Up to 2 weeks.)
  • Delirium.(Up to 2 weeks.)
  • Postoperative packed red blood cells transfusion.(Up to 1 week.)

Investigators

Sponsor
JESSICA GARCIA SUAREZ
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

JESSICA GARCIA SUAREZ

Principal investigator

Puerta de Hierro University Hospital

Study Sites (1)

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