Prevalence of Liver Dysfunction in Pediatric Patients With Congenital Heart Disease at Assiut.

ConditionsCongenital Heart Disease Liver Dysfunction

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 16

SponsorAssiut University

About this trial

Liver dysfunction is a well-documented complication in patients with congenital heart disease (CHD). The mechanisms leading to hepatic dysfunction may be multifactorial. Key risk factors for liver dysfunction in CHD include prolonged hypoxemia, high venous pressure, and prolonged duration of heart disease.

While global studies have extensively explored this association, the prevalence of liver dysfunction in CHD varies, with studies reporting hepatic fibrosis in 30-40% of Fontan patients, while regional data, particularly from Egypt, remain limited.

In this research we aim to determine the prevalence of biochemical and radiological hepatic abnormalities in pediatric CHD patients attending Assiut University Children's Hospital.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed pediatric CHD patients attending Assiut University Children's Hospital.

Age: from birth up to 16 years old.

Disqualifiers

Patients with primary liver disease.

Recent cardiac surgery (<3 m) (to exclude acute postoperative liver injury).

Active systemic infection/sepsis (to avoid confounding liver enzyme elevations).

Trial design

Design model

Single group

Treatments tested in this trial

Ultrasonography
Diagnostic test
Ultrasound, also known as sonography or ultrasonography, is a medical imaging technique that uses high-frequency sound waves to create real-time images of internal body structures
Blood Sampling
Procedure/Surgery
To assess hepatic function in congenital heart disease (CHD) patients, blood samples will be collected from all patients in our study for: * Alanine Transferase (ALT). * Aspartate Aminotransferase (AST). * Gamma Glutamyl Transferase (GGT). * Alkaline Phosphatase (ALP). * Total/direct bilirubin. * Albumin. * Prothrombin time. * International Normalized Ratio (INR). * Platelet count.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: CHD patientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

To assess the prevalence of hepatic dysfunction among CHD

To assess the prevalence of hepatic dysfunction among CHD patients attending Assiut University Children's Hospital

Time frame

5 months

Secondary outcomes

To classify hepatic dysfunction with CHD

To classify hepatic dysfunction with CHD using the APRI index into mild, moderate, and severe.

Time frame

4 months

Sponsors and contacts

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Assiut University

Lead sponsor

Source ClinicalTrials.gov

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