Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery

NCT04094168 | Completed Phase 4 DMC

• 1 other identifier: EUDRA CT 2017-005144-14
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Keywords

Del Nido Cardioplegia; Cardioplegia; Adult Cardiac Surgery; Myocardial protection; Heart surgery

Outcome Measures

Primary Outcomes (2)

• Blood troponin levels.

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

  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.

  Up to 72 hours

Secondary Outcomes (21)

• Ventricular fibrillation after aortic cross-clamp removal.

  Intraoperative.

• Defibrillation requirement.

  Intraoperative.

• Cardioplegia delivery.

  Intraoperative.

• Cardiopulmonary bypass time (CBP).

  Intraoperative.

• Aortic cross-clamp time

  Intraoperative.

Study Arms (2)

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.

Drug: DEL NIDO CARDIOPLEGIA

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.

Drug: COLD BLOOD BASED CARDIOPLEGIA

Interventions

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.

Del Nido Cardioplegia solution

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.

Also known as: CARDIBRAUN

Cold blood Cardioplegia solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 years or older undergoing adult cardiac surgery.
• Elective surgical procedures requiring cardiopulmonary bypass and myocardial arrest.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JESSICA GARCIA SUAREZ: lead

Study Sites (1)

Puerta de Hierro Hospital

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (7)

• Buckberg GD, Athanasuleas CL. Cardioplegia: solutions or strategies? Eur J Cardiothorac Surg. 2016 Nov;50(5):787-791. doi: 10.1093/ejcts/ezw228. Epub 2016 Jul 1. No abstract available.

  PMID: 27369117 BACKGROUND

• Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.

  PMID: 29246552 BACKGROUND

• Li Y, Lin H, Zhao Y, Li Z, Liu D, Wu X, Ji B, Gao B. Del Nido Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Systematic Review and Meta-Analysis. ASAIO J. 2018 May/Jun;64(3):360-367. doi: 10.1097/MAT.0000000000000652.

  PMID: 28863040 BACKGROUND

• Lazar HL. del Nido cardioplegia: Passing fad or here to stay? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1009-1010. doi: 10.1016/j.jtcvs.2017.09.126. Epub 2017 Oct 10. No abstract available.

  PMID: 29110949 BACKGROUND

• Tam DY, Fremes SE. Del Nido cardioplegia: A one stop shot for adult cardiac surgery? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1019-1020. doi: 10.1016/j.jtcvs.2017.10.066. Epub 2017 Oct 31. No abstract available.

  PMID: 29198802 BACKGROUND

• Garcia-Suarez J, Garcia-Fernandez J, Martinez Lopez D, Reques L, Sanz S, Carballo D, Martin CE, Ospina VM, Villar S, Martin A, Casado M, Villafranca A, Gonzalez AI, Serrano S, Forteza A. Clinical impact of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2023 Nov;166(5):1458-1467. doi: 10.1016/j.jtcvs.2022.01.044. Epub 2022 Feb 8.

  PMID: 35279289 DERIVED

• Garcia-Suarez J, Garcia Fernandez J, Sanz S, Martinez Lopez D, Reques L, Forteza Gil A. Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17826. doi: 10.2196/17826.

  PMID: 32673265 DERIVED

MeSH Terms

Interventions

Del Nido cardioplegia solution

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 18, 2019
• Study Start: June 15, 2018
• Primary Completion: December 15, 2019
• Study Completion: February 28, 2020
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months after publication.
• Access Criteria: Access by mail to principal investigator: Jessica.suarez@gmail.com Access by mail to sponsor: apforteza@yahoo.es

Locations

ES (1)