Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors

CKD Clinical Trial

Official title:

Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437418
• Other study ID #: Gallbladder dysfunction in CKD
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Rehab Mohamed Mohamed Eltayeb, M.B.B.CH.
• Phone: 01016644593
• Email: rehab.eltaib[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Our aim in this cross-sectional study is to determine the frequency and aspects of gallbladder dysfunction and the related risk factors in pre-ESRD and hemodialysis patients.

Description:

Biliary tract disorders including cholelithiasis, cholecystitis, and other diseases of the biliary tract, are one of the most prevalent medical issues in the digestive system, posing a myriad of challenges for health workers and patients. Gallbladder dysfunction is the most frequent cause of symptomatic and complicated biliary tract disorders. Although gallbladder dysfunction is a common condition in Middle East countries, data on the incidence of end-stage renal disease (ESRD) are limited. The occurrence of gallbladder dysfunction in patients fed with low-protein diets suggests that gallbladder stones formation is affected by dietary protein content. Also the lithogenic composition changes of bile, increased nucleation tendency, and impaired motility of gallbladder are important factors in ESRD patients. It has been reported that chronic kidney disease (CKD) patients on regular hemodialysis (HD) have increased bile cholesterol levels and an increased bile saturation index. In addition, the gallbladder is innervated by the autonomic nervous system, which malfunctions in uremia, and it has been shown that gallbladder stasis might cause increased stone formation. In some studies, the prevalence of gallbladder dysfunction has been shown to increase in patients undergoing hemodialysis (HD) treatment for ESRD. So, we focused in this study to try to find association of gallbladder dysfunction in pre-dialysis ESRD and HD patient in comparison to normal renal function individuals.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients who are diagnosed as CKD with eGFR according to Cockcroft-Gault Equation, whatever they are on regular hemodialysis or pre-dialysis without history of previous gallbladder dysfunction with normal renal function individuals.

Exclusion Criteria:

• Patients who are younger than 18 years.
• Patients who are diabetic.
• Patients who have body mass index (BMI) more than 30.
• Patients who have family history of gallbladder disorder.

Related Conditions & MeSH terms

• Biliary Tract Diseases
• CKD
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• abdominal ultrasonography.
Evaluate the gallbladder ejection fraction (EF)

Locations

Country	Name	City	State
Egypt	faculty of medicine Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gallbladder dysfunction in CKD patients	Evaluate the gallbladder ejection fraction (EF) which will be calculated by following formula. (EF = (fasting gallbladder volume (FV) - residual gallbladder volume (RV)) / fasting gallbladder volume (FV)x 100) EF = (FV - RV) / FV x 100	measuring fasting gallbladder volume (FV) after 10 overnight hours fasting and the residual gallbladder volume (RV) after 30 minutes after standard fixed meal