Skip to main content
Clinical Trials/NCT05797090
NCT05797090
Completed
Not Applicable

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

mohamed1 site in 1 country80 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Crystalloid Cardioplegic solution
Conditions
Mitral Valve Surgery
Sponsor
mohamed
Enrollment
80
Locations
1
Primary Endpoint
myocardial protection
Status
Completed
Last Updated
2 years ago

Overview

Brief 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

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
March 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
mohamed
Responsible Party
Sponsor Investigator
Principal Investigator

mohamed

Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine - Al-Azhar University

Azhar University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

crystalloid cardioplegia with modified del Nido cardioplegia

To compare between conventional crystalloid cardioplegia with modified del Nido cardioplegia in mitral valve regurge replacement surgery.

Intervention: Crystalloid Cardioplegic solution

Outcomes

Primary Outcomes

myocardial protection

Time Frame: from baseline to 24 hours after the operation

Number of Participants With myocardial protection through measurements of the serum levels of the cardiac enzymes just after operation

Study Sites (1)

Loading locations...

Similar Trials