Modified Del Nido Versus Custodiol Cardioplegia For Myocardial Protection In Cardiac Surgery.

NCT05221294 | Completed

• 1 other identifier: R193
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Cardioplegia solutions have been considered as a corner stone for myocardial protection during cardiac surgery with cardiopulmonary bypass and cardiac arrest, it limits the metabolic activity and increases the capacity of the myocardium to withstand prolonged ischemic time, and thus it has a direct impact on surgical outcomes. (1, 2) Long acting cardioplegic solutions with a single dose strategy are beneficial as they allow surgery without interruptions, reducing cross clamp time and provide more cardiac protection. (3) Custodiol (histidine- tryptophan- ketoglutarate) solution has been described in the 1970s by Bretschneider (4), and used as an alternative to hyperkalemic crystalloid solutions especially during complex cardiac surgeries, also used for organ preservation during transplant surgery. (5, 6) In the 1990s Pedro del Nido and his team introduced a new cardioplegic solution (del Nido cardioplegia) for pediatric cardiac surgeries. (7) But recently, many studies postulated its use for adults. (8) The base solution for the traditional del Nido cardioplegia is Plasma-Lyte A which is a calcium free solution and electrolyte composition similar to the extracellular fluid. (7) However Plasma-Lyte A is unavailable in many countries, this precludes its use. Some authors have advocated lactated Ringer's as a base solution instead of Plasma-Lyte A for preparing del Nido cardioplegia, now known as modified del Nido cardioplegia. (9) Custodiol and modified del Nido cardioplegia can be used in a single dose fashion with proper myocardial protection and minimal surgical interruptions. However, the literature also does not confirm the superiority of one over another. (1) Also, limited number of clinical trials compared both cardioplegic solutions directly. So, in this study we aimed to assess the efficacy of both Custodiol and modified del Nido cardioplegia in myocardial protection and clinical outcomes among adult patients undergoing cardiac surgery.

Conditions

Cardioplegia Solution Adverse Reaction

Keywords

Myocardial Protection; Custodiol Cardioplegia; Del Nido

Outcome Measures

Primary Outcomes (1)

• troponin I

  troponin I at 24 hours after surgery to assess myocardial protection between the two used cardioplegia solutions.

  24 hours after surgery

Secondary Outcomes (12)

• The total volume of cardioplegia solution

  In the first 24 hours of surgery

• Total cross-clamp time and total CPB time

  In the first 24 hours of surgery

• Incidence of ventricular fibrillation after cross-camp removal

  In the first 24 hours of surgery

• Postoperative left ventricular ejection fraction

  24 hours after surgery in days

• Requirement of inotropes and time of discontinuation

  postoperative 24 hours

Study Arms (2)

MDN group

EXPERIMENTAL

will receive modified Del Nido cardioplegia solution

Drug: Modified Del Nido Versus Custodiol Cardioplegia

C group

EXPERIMENTAL

will receive Custodiol cardioplegia

Drug: Modified Del Nido Versus Custodiol Cardioplegia

Interventions

Modified Del Nido Versus Custodiol Cardioplegia DRUG

Modified Del Nido Versus Custodiol Cardioplegia For Myocardial Protection In Cardiac Surgery

C group; MDN group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients ≥ 18 years old, scheduled for elective valve replacement surgery or coronary artery bypass grafting surgery.

You may not qualify if:

• Emergency surgery.
• Chronic kidney disease.
• Hepatic impairment.
• Re-do surgery.
• Severe psychiatric illness.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related Publications (3)

• Sanetra K, Pawlak I, Cisowski M. Del Nido cardioplegia - what is the current evidence? Kardiochir Torakochirurgia Pol. 2018 Jun;15(2):114-118. doi: 10.5114/kitp.2018.76477. Epub 2018 Jun 25.

  PMID: 30069192 RESULT

• Vivacqua A, Robinson J, Abbas AE, Altshuler JM, Shannon FL, Podolsky RH, Sakwa MP. Single-dose cardioplegia protects myocardium as well as traditional repetitive dosing: A noninferiority randomized study. J Thorac Cardiovasc Surg. 2020 May;159(5):1857-1863.e1. doi: 10.1016/j.jtcvs.2019.03.125. Epub 2019 May 11.

  PMID: 31204129 RESULT

• Abdelhady MA, Goda AS, Sayed Gomaa MS, Hamed MA, Hassan AASM. Modified Del Nido Versus Custodiol(R) Cardioplegia for Myocardial Protection in Adult Patients Undergoing Cardiac Surgery; A Prospective Randomized Double-Blinded Clinical Trial. Ann Card Anaesth. 2025 Oct 1;28(4):451-458. doi: 10.4103/aca.aca_35_25. Epub 2025 Oct 13.

  PMID: 41081689 DERIVED

Study Officials

• Mohamed Hamed, M.D

  Fayoum University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fayoum University Hospital

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 2, 2022
• Study Start: February 1, 2022
• Primary Completion: November 15, 2023
• Study Completion: November 30, 2023
• Last Updated: January 3, 2024

Record last verified: 2022-10

Locations

EG (1)