Myocardial Biopsy in Congenital Cardiac Surgery

NCT ID: NCT03595111

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2018-12-31

Brief Summary

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Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.

Detailed Description

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Myocardial sample was obtained from the endocardial surface of the right ventricle and placed in formalin until examination under light microscopy for detection of myocyte cellular edema as a marker of ischemic changes.

Conditions

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Myocardial Protection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Myocardial cell edema either focal or diffuse was detected in histopathological examination in pediatric patients undergoing total repair of Tetrology of Fallout
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Myocardial biopsy

The specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change.

Group Type EXPERIMENTAL

myocardial biopsy

Intervention Type PROCEDURE

Myocardial cell edema either focal or diffuse was detected in histopathological examination

Interventions

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myocardial biopsy

Myocardial cell edema either focal or diffuse was detected in histopathological examination

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes.

Hemodynamic stability.

Exclusion Criteria

Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sayed Kaoud Abd-Elshafy

Associate Profossor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IRB00008715964

Identifier Type: -

Identifier Source: org_study_id

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