Cardiac IschemiaPhase 3HTKNCT06414330
Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus HTK Solution Cardioplegia Solution in Cardiac Surgery
A Phase 3 study testing Ringer acetate based Del Nido cardioplegia and HTK in people with Cardiac Ischemia, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Ischemia
- What is being tested?
- Ringer acetate based Del Nido cardioplegia and HTK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Any gender
- Surgery demands cardiopulmonary bypass and cardioplegia.
- CABG surgeries
Who cannot join
- < 18 years old
- Emergency surgeries
- Off pump CABG surgeries
- Taking cardioplegia other than Del Nido or HTK cardioplegia
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university, faculty of medicine, anesthesia and ICU and pain management department
Asyut, Asyut Governorate, 71515
About this study
Official title: Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus Histidine, Tryptophan and Ketoglutarate 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
Read the 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
- Being tested
- Ringer acetate based Del Nido cardioplegia, HTK
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer acetate based Del Nido cardioplegiaBiological
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.
HTKBiological
Giving HTK instead of Del Nido
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Biological: Ringer acetate based Del Nido cardioplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after aortic declamping and reperfusion of the heart at the end of ischemia time during cardiopulmonary bypass
Secondary outcomes (2)
postoperative serum troponin
serum level of troponin in microgram in deciliter
Measured: 24 hour postoperatively
postoperative echocardiography
for any new change from preoperative status
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024
- Primary completion12 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac IschemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmed Ismail Abdelsabour, Ramy Mustafa Abdelgawad Mohamed, Ibrahim Mohamed Imbaby, Amr Ibrahim Abdelaal, Mahmoud Mohamed Atef Sallam, Mohamed, Ahmed Abdelhay Mohamed
- Responsible party
- Principal investigator, Ayman Abd El-Khalek Mohammed Glala, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414330
- Sponsor's protocol ID
- Delnido cardioplegia
- Acronym
- HTK
- Status last verified
- Dec 2025
- First submitted
- 7 May 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus Histidine, Tryptophan and Ketoglutarate Solution Cardioplegia Solution in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06414330
- Acronym / sponsor ID
- HTK / Delnido cardioplegia
- Conditions
- Cardiac Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Ahmed Ismail Abdelsabour, Ramy Mustafa Abdelgawad Mohamed, Ibrahim Mohamed Imbaby, Amr Ibrahim Abdelaal, Mahmoud Mohamed Atef Sallam, Mohamed, Ahmed Abdelhay Mohamed
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTK custidiol | Experimental | Biological: HTKwill 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. |
| Del Nido | Experimental | Biological: Ringer acetate based Del Nido cardioplegiawill 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years old
- Any gender
- Surgery demands cardiopulmonary bypass and cardioplegia.
- CABG surgeries
Key exclusion criteria (4 listed)
- < 18 years old
- Emergency surgeries
- Off pump CABG surgeries
- Taking cardioplegia other than Del Nido or HTK cardioplegia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer acetate based Del Nido cardioplegiaAll 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. | Biological | Del Nido |
| HTKGiving HTK instead of Del Nido | Biological | HTK custidiol |
Primary outcome
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.
2 secondary outcomes
postoperative serum troponin
Time frame: 24 hour postoperatively
postoperative echocardiography
Time frame: 24 hour postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ringer acetate based Del Nido cardioplegia and HTK in people with Cardiac Ischemia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.