Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia

NCT06287372 | Completed

• 1 other identifier: 3261
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to investigate intra-operative changes in markers of myocardial injury and myocardial intracellular amino acids during ischemia and reperfusion, comparing two methods of myocardial protection; Calafiore intermittent antegrade warm blood cardioplegia or modified del Nido intermittent antegrade cold blood cardioplegia in routine coronary artery bypass grafting procedures.

Conditions

Myocardial Injury; Cardiac Surgery; Myocardial Protection

Keywords

cardioplegia; coronary artery bypass grafting; amino acid

Outcome Measures

Primary Outcomes (1)

• Changes in markers of myocardial injury

  Changes in release of myocardial CK-MB and troponin I

  4, 12, 24 and 48 hours postoperatively

Secondary Outcomes (1)

• Changes in myocardial amino acid concentrations

  2-3 hours

Study Arms (2)

Group 1: Calafiore cardioplegia

Patients were randomly assigned to undergo surgery using one of two methods for myocardial protection: • Group 1: Calafiore intermittent antegrade warm blood cardioplegia (consisting of normothermic pump blood, potassium chloride 2 mEq/ml and magnesium sulfate 50%). This cardioplegic solution was administered at 37 degrees C following application of the aortic cross-clamp and repeated after completion of each distal coronary anastomosis as described previously.

Other: Cardioplegic solution

Group 2: del Nido cardioplegia

• Group 2: Modified del Nido intermittent antegrade cold blood cardioplegic solution (consisting of 750 ml of lactated Ringer solution, 200 ml of pump blood, 13 ml of sodium bicarbonate 8.4%, 16 ml of mannitol 20%, 4 ml of magnesium sulfate 50%, 13 ml of lidocaine 2% and 13 ml of potassium chloride 2 mEq/ml). This solution was administered as a 1-liter bolus at 3-4 degrees C following application of the aortic cross-clamp, and repeated as a 500 ml bolus if cross-clamp time extended beyond 60 minutes (none of the patients in this study).

Other: Cardioplegic solution

Interventions

Cardioplegic solution OTHER

Patients were randomly assigned to undergo surgery using one of two methods for myocardial protection

Group 1: Calafiore cardioplegia; Group 2: del Nido cardioplegia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled in this study

You may qualify if:

• All consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled in this study.

You may not qualify if:

• Patients were excluded from this study if they had suffered from previous myocardial infarction, had reduced ejection fraction or were undergoing combined or repeated surgery.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University Cardiac Surgery Hospital

Damascus, Syria

Location

MeSH Terms

Interventions

Cardioplegic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Mohammad Bashar Izzat

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: July 4, 2022
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

SY (1)