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CompletedNCT05797090Updated May 6, 2023

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

An interventional study of Crystalloid Cardioplegic solution in Mitral Valve Surgery, sponsored by mohamed. Completed at 1 site in Egypt. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by mohamed · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
21 Years to 50 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Mitral Valve Surgery
03

In context

Lead sponsor

mohamed is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • 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

Interventions

  • DrugCrystalloid Cardioplegic solution

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

    Also known as: Modified Del Nido Cardioplegia

06

What researchers measure

Primary outcomes

  1. myocardial protection

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

    Time frame: from baseline to 24 hours after the operation

07

Study locations

1 site
  • Azhar University
    Cairo, 11765, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05797090
Lead sponsor
mohamed
Collaborators
Azhar University
Responsible party
mohamed (Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine - Al-Azhar University, Azhar University) — Sponsor-investigator
First posted
Apr 4, 2023
Start date
Jul 1, 2022
Primary completion
Mar 1, 2023
Completion
Mar 15, 2023
Last update
May 6, 2023

Study contacts

Mohamed Abdel-Gawad, Lecturer
principal investigator · Faculty of Medicine - Al-Azhar University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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