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NCT Number: NCT04094168

Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery

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.

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Key information

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Puerta de Hierro Hospital

Majadahonda, Madrid, 28222, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DEL NIDO CARDIOPLEGIA

Drug

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.

COLD BLOOD BASED CARDIOPLEGIA

Drug

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.

Other names: CARDIBRAUN

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Ventricular fibrillation after aortic cross-clamp removal.

    Time frame: Intraoperative.

    Incidence of ventricular fibrillation after aortic cross-clamp removal (Y/N).

  2. Defibrillation requirement.

    Time frame: Intraoperative.

    Defibrillation requirement after aortic cross-clamp removal (Y/N).

  3. Cardioplegia delivery.

    Time frame: Intraoperative.

    Cardioplegia delivery (antegrade, retrograde, both).

  4. Cardiopulmonary bypass time (CBP).

    Time frame: Intraoperative.

    Duration of cardiopulmonary bypass (CBP) (min).

  5. Aortic cross-clamp time

    Time frame: Intraoperative.

    Duration of aortic cross-clamp time (min).

  6. Return to cardiopulmonary bypass.

    Time frame: Intraoperative

    Failure to separate from cardiopulmonary bypass (Y/N).

  7. Intraoperative packed red blood cells transfusion.

    Time frame: Intraoperative

    Intraoperative packed red blood cells transfusion (U).

  8. Intraoperative maximal blood glucose concentration.

    Time frame: Intraoperative

    Intraoperative maximal blood glucose concentration (mg/dl).

  9. Postoperative atrial fibrillation.

    Time frame: Up to 2 weeks.

    New-onset atrial fibrillation or hemodynamically unstable atrial fibrillation that requires treatment (Y/N).

  10. Reoperation.

    Time frame: Up to 24 hours.

    Reoperation within 24 hours after surgery (Y/N).

  11. Inotropic or vasopressor support in intensive care unit.

    Time frame: At admission in intensive care unit, 24, 48 hours.

    Inotropic or vasopressor support in intensive care unit (Y/N).

  12. Duration of inotropic support after cardiopulmonary bypass.

    Time frame: Up to 2 weeks.

    Duration of inotropic support after cardiopulmonary bypass (hours).

  13. Time to extubation.

    Time frame: Up to 2 weeks.

    Mechanical ventilation time (min).

  14. Acute renal failure.

    Time frame: Up to 2 weeks.

    Incidence of renal failure (Requirement for postoperative renal replacement therapy) (Y/N).

  15. Ischemic stroke.

    Time frame: Up to 2 weeks.

    Incidence of ischemic stroke (Y/N).

  16. Delirium.

    Time frame: Up to 2 weeks.

    Incidence of delirium (Y/N).

  17. Postoperative packed red blood cells transfusion.

    Time frame: Up to 1 week.

    Postoperative packed red blood cells transfusion (U)

  18. Length of stay in intensive care unit

    Time frame: through study completion, an average 1 month.

    Length of stay in intensive care unit (days).

  19. Length of stay in hospital

    Time frame: through study completion, an average 6 months.

    Length of stay in hospital (days).

  20. Postoperative ventricular ejection fraction change.

    Time frame: through study completion, an average 6 months.

    Postoperative ventricular ejection fraction (LVEF) change (Y/N).

  21. Mortality.

    Time frame: through study completion, an average 6 months.

    Mortality (Y/N).

Sponsors and collaborators

Lead sponsor

JESSICA GARCIA SUAREZ

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 18, 2019
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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