Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus HTK Solution Cardioplegia Solution in Cardiac Surgery

NCT06414330 | Completed Phase 3

• 1 other identifier: Delnido cardioplegia
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Low chloride solutions were proved to be better in resuscitation of emergency cases and decrease the resulting hyperchloremic metabolic acidosis in the last decade. In ringers' acetate solutions, there is acetate, which is metabolized in muscles to produce bicarbonate molecules, so neutralizing the ongoing lactic and hyperchloremic metabolic solutions. Both solutions were proved to be superior to normal saline as a fluid therapy plan in most studies with much less ongoing hyperchloremic metabolic acidosis and inflammatory response. In this protocol, modified Del Nido formula will be involved using ringers' acetate instead of plasmalyte solutions and comparing the effects on myocardial protection versus HTK solutions

Conditions

Cardiac Ischemia

Outcome Measures

Primary Outcomes (1)

• Any arrhythmia other than sinus rhythm after cross-clamp removal and reperfusion

  Sinus rhythm will be defined by the following criteria: Del Nido cardioplegia vs HTK. Regular rhythm at a rate of between 60 to 100bpm. - Presence of P waves that are followed by a QRS complex at a 1:1 rate. - A PR interval of between 120 and 200ms.

  after aortic declamping and reperfusion of the heart at the end of ischemia time during cardiopulmonary bypass

Secondary Outcomes (2)

• postoperative serum troponin

  24 hour postoperatively

• postoperative echocardiography

  24 hour postoperative

Study Arms (2)

HTK custidiol

EXPERIMENTAL

will receive HTK (Histidine, Tryptophan and Ketoglutarate solution) consisting of (1000ml distilled water, sodium 15mmol/L, potassium 9mmol/L, magnesium 4mmol/L, calcium 0.015 mmol/L, histidine 129mmol/L, tryptophan 2mmol/L, ketoglutarate 1mmol/L, mannitol 30mmol and pH 7.02 - 1.2). Dose will be 10 - 20 ml/kg and can be repeated once after 120 minutes.

Biological: HTK

Del Nido

EXPERIMENTAL

will receive modified Del Nido cardioplegia (Ringer acetate 1000ml, mannitol 20% 17 ml, magnesium sulphate 10% 20ml, sodium bicarbonate 8.4% 16ml, potassium chloride 7.5% 13ml and lidocaine 2% 8 ml). Crystalloid to blood ratio will be 80% to 20% respectively. Dose will be 15 - 20 ml/kg in first dose then 8 - 10 ml/kg every 60 minutes

Biological: Ringer acetate based Del Nido cardioplegia

Interventions

HTK BIOLOGICAL

Giving HTK instead of Del Nido

HTK custidiol

Ringer acetate based Del Nido cardioplegia BIOLOGICAL

All patients will receive hypothermia 29 - 32 ℃ and cardioplegia will be injected between the aortic valve and aortic cross clamp in a pressure not less than 50 mmHg above systolic pressure. After removal of aortic cross clamping, the heart will be monitored for ventricular arrhythmias, early recovery, and postoperative 24 hours serum troponin and new changes in echocardiography.

Del Nido

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old
• Any gender
• Surgery demands cardiopulmonary bypass and cardioplegia.
• CABG surgeries

You may not qualify if:

• \< 18 years old
• Emergency surgeries
• Off pump CABG surgeries
• Taking cardioplegia other than Del Nido or HTK cardioplegia

Sponsors & Collaborators

• Assiut University: lead
• Ahmed Ismail Abdelsabour: collaborator
• Ramy Mustafa Abdelgawad Mohamed: collaborator
• Ibrahim Mohamed Imbaby: collaborator
• Amr Ibrahim Abdelaal: collaborator
• Mahmoud Mohamed Atef Sallam: collaborator
• Mohamed, Ahmed Abdelhay Mohamed: collaborator

Study Sites (1)

Assiut university, faculty of medicine, anesthesia and ICU and pain management department

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion: November 12, 2025
• Study Completion: December 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

EG (1)