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NCT Number: NCT06414330

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Asyut, Asyut Governorate, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

HTK

Biological

Giving HTK instead of Del Nido

Primary outcomes

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

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

    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.

Secondary outcomes

  1. postoperative serum troponin

    Time frame: 24 hour postoperatively

    serum level of troponin in microgram in deciliter

  2. postoperative echocardiography

    Time frame: 24 hour postoperative

    for any new change from preoperative status

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Ahmed Ismail Abdelsabour
  • Amr Ibrahim Abdelaal
  • Ibrahim Mohamed Imbaby
  • Mahmoud Mohamed Atef Sallam
  • Mohamed, Ahmed Abdelhay Mohamed
  • Ramy Mustafa Abdelgawad Mohamed

Registry information

Official study title

Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus Histidine, Tryptophan and Ketoglutarate Solution Cardioplegia Solution in Cardiac Surgery

Acronym: HTK

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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