## Protocol Section
### Identification Module
**NCT ID:** NCT06414330

**Acronym:** HTK

**Brief Title:** 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

#### Organization Study ID Info
**ID:** Delnido cardioplegia
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2024-11-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Ahmed Ismail Abdelsabour

**Class:** UNKNOWN

**Name:** Ramy Mustafa Abdelgawad Mohamed

**Class:** UNKNOWN

**Name:** Ibrahim Mohamed Imbaby

**Class:** UNKNOWN

**Name:** Amr Ibrahim Abdelaal

**Class:** UNKNOWN

**Name:** Mahmoud Mohamed Atef Sallam

**Class:** UNKNOWN

**Name:** Mohamed, Ahmed Abdelhay Mohamed

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Ayman Abd El-Khalek Mohammed Glala

**Investigator Title:** principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Cardiac Ischemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 124

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Biological: HTK

**Label:** HTK custidiol

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Biological: Ringer acetate based Del Nido cardioplegia

**Label:** Del Nido

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Del Nido

**Description:** 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.

**Name:** Ringer acetate based Del Nido cardioplegia

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- HTK custidiol

**Description:** Giving HTK instead of Del Nido

**Name:** HTK

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

#### Secondary Outcomes

**Description:** serum level of troponin in microgram in deciliter

**Measure:** postoperative serum troponin

**Time Frame:** 24 hour postoperatively

**Description:** for any new change from preoperative status

**Measure:** postoperative echocardiography

**Time Frame:** 24 hour postoperative

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Cardiac Ischemia

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Cardiac Ischemia

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Analg

- Name: Analgesics

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: CaS

- Name: Cardioplegic Solutions

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M11270

- Name: Magnesium Sulfate

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M11342

- Name: Mannitol

- Relevance: LOW

- As Found: Unknown

- ID: M17115

- Name: Tryptophan

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M5570

- Name: Cardioplegic Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M274130

- Name: Del Nido cardioplegia solution

- Relevance: LOW

- As Found: Unknown

- ID: T21

- Name: Tryptophan

- Relevance: LOW

- As Found: Unknown

- ID: T8

- Name: Histidine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
