Comparative Study Between Conventional Crystalloid Cardioplegic Solution With Modified Del Nido Cardioplegia

Comparative Study Between Conventional Crystalloid Cardioplegic Solution With Modified Del Nido Cardioplegia in Mitral Valve Regurgitation Surgery

Mitral valvuloplasty for correction of chronic mitral regurgitation carries a lower operative mortality and morbidity and improved long-term survival than does mitral valve replacement. Unfortunately, mitral valvuloplasty is not possible in all patients with chronic mitral regurgitation because of unfavorable pathology or lack of experience with this technique

Study Overview

• Status: Completed
• Conditions: Mitral Valve Surgery
• Intervention / Treatment: Drug: Crystalloid Cardioplegic solution

Detailed Description

Cardioplegia is a fundamental component in providing heart protection, limiting metabolic activity and increasing the myocardium's capacity to resist ischemia for prolonged periods, thus being essential for good surgical outcomes.

Numerous cardioplegia solutions exist with different compositions to provide sufficient myocardial protection. However, there is no standard for the optimal or ideal composition and delivery technique. Cardioplegia solutions are crystalloid or blood-based solutions with various chemical compounds.

Despite improvements in myocardial protection, prosthetic valves, surgical techniques, and postoperative care, the operative mortality and morbidity of mitral valve replacement for chronic mitral regurgitation remains high in comparison with other commonly performed heart operations.

The timing of the administration of cardioplegia is extremely important in terms of preventing myocardial dysfunction. Conventional multidose cardioplegias should be repeatedly administered in every 15 to 20 min. Frequent interruption of the surgical process, even for a short time, before each cardioplegia delivery leads to a loss of time during open heart surgery, where time is extremely important, and disrupts the coherence of the operation and the surgical concentration.

Crystalloid cardioplegic solutions achieve cardioplegic arrest through inhibition of either fast-acting sodium channels or calcium-activated mechanisms. Hyperkalemia can be used to inhibit the fast-acting sodium channels as it is in the St.Thomas Hospital solution and its modifications.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11765
    • Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patients scheduled for elective Mitral regurge replacement Surgery with normal Coronaries

Exclusion Criteria:

1. Patients with chronic renal disease (previous medical diagnosis or serum creatinine greater than 1.5mg/dL)
2. Left ventricular ejection fraction less than 50%.
3. Previous cardiac surgery
4. Patient with BMI > 30
5. Severe psychiatric illness
6. Inability or unwillingness to give informed consent for participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: crystalloid cardioplegia with modified del Nido cardioplegia; To compare between conventional crystalloid cardioplegia with modified del Nido cardioplegia in mitral valve regurge replacement surgery.	Drug: Crystalloid Cardioplegic solution; To compare between conventional crystalloid cardioplegia with modified del Nido cardioplegia in mitral valve regurge replacement surgery.; Other Names: Modified Del Nido Cardioplegia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
myocardial protection	Number of Participants With myocardial protection through measurements of the serum levels of the cardiac enzymes just after operation	from baseline to 24 hours after the operation

Collaborators and Investigators

• Sponsor: mohamed
• Collaborators: Azhar University
• Investigators: Principal Investigator: Mohamed Abdel-Gawad, Lecturer, Faculty of Medicine - Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: April 1, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Cardioplegic Solutions
• Other Study ID Numbers: Moustafa Omara

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No