Clinical trial NCT06414330: Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus HTK Solution Cardioplegia Solution in Cardiac Surgery
Official title: Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus Histidine, Tryptophan and Ketoglutarate Solution Cardioplegia Solution in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Ischemia
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Ahmed Ismail Abdelsabour
name: Ramy Mustafa Abdelgawad Mohamed
name: Ibrahim Mohamed Imbaby
name: Amr Ibrahim Abdelaal
name: Mahmoud Mohamed Atef Sallam
name: Mohamed, Ahmed Abdelhay Mohamed
First posted: 2024-05-16
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Any arrhythmia other than sinus rhythm after cross-clamp removal and reperfusion
timeFrame: after aortic declamping and reperfusion of the heart at the end of ischemia time during cardiopulmonary bypass
Secondary outcomes:
measure: postoperative serum troponin
timeFrame: 24 hour postoperatively
measure: postoperative echocardiography
timeFrame: 24 hour postoperative
Other outcomes:
Locations:
Study officials:
References: