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

Mitral Valve Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05797090
• Other study ID #: Moustafa Omara
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: May 2023
• Source: Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 15, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Surgery

Intervention

Drug:
• Crystalloid Cardioplegic solution
To compare between conventional crystalloid cardioplegia with modified del Nido cardioplegia in mitral valve regurge replacement surgery.

Locations

Country	Name	City	State
Egypt	Azhar University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
mohamed	Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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