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Completed

NCT Number: NCT05797090

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

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

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Key information

Conditions

Mitral Valve Surgery

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azhar University

Cairo, 11765, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crystalloid Cardioplegic solution

Drug

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

Other names: Modified Del Nido Cardioplegia

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

mohamed

Other

Collaborators

  • Al-Azhar University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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