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

NCT ID: NCT06414330

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-12-01

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

Detailed Description

First, fulfilling all inclusion criteria and consent acceptance for study are to be confirmed. Preoperative evaluation is done for full laboratory investigations including CBC, coagulation, renal and liver functions, CRP and troponin, full clinical examination for chest and heart, coronary angiography, Echocardiography, carotid doppler and upper and lower venous and arterial doppler are to be done. All patients will be scheduled for on pump CABG surgery. Low dose of midazolam will be given before surgery. Intraoperative monitoring will involve invasive blood pressure, ECG, peripheral pulse oximetry, capnogram.

After induction of anaesthesia and median sternotomy, patients will be randomly allocated into two groups:

Group (D) 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.

Group (C ) 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.

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.

Conditions

Cardiac Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HTK custidiol

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.

Group Type: EXPERIMENTAL

HTK

Intervention Type: BIOLOGICAL

Giving HTK instead of Del Nido

Del Nido

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

Group Type: EXPERIMENTAL

Ringer acetate based Del Nido cardioplegia

Intervention Type: 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.

Interventions

Ringer acetate based Del Nido cardioplegia

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.

Intervention Type: BIOLOGICAL

HTK

Giving HTK instead of Del Nido

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years old

2. Any gender

3. Surgery demands cardiopulmonary bypass and cardioplegia.

4. CABG surgeries

Exclusion Criteria

1. < 18 years old

2. Emergency surgeries

3. Off pump CABG surgeries

4. Taking cardioplegia other than Del Nido or HTK cardioplegia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Ismail Abdelsabour

UNKNOWN

Sponsor Role: collaborator

Ramy Mustafa Abdelgawad Mohamed

UNKNOWN

Sponsor Role: collaborator

Ibrahim Mohamed Imbaby

UNKNOWN

Sponsor Role: collaborator

Amr Ibrahim Abdelaal

UNKNOWN

Sponsor Role: collaborator

Mahmoud Mohamed Atef Sallam

UNKNOWN

Sponsor Role: collaborator

Mohamed, Ahmed Abdelhay Mohamed

UNKNOWN

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Abd El-Khalek Mohammed Glala

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

Delnido cardioplegia

Identifier Type: -

Identifier Source: org_study_id