CKDNCT06437418
Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors
An observational study of CKD and Gall Bladder Dysfunction, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- CKD, Gall Bladder Dysfunction
- What is being tested?
- abdominal ultrasonography.
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2024to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: individuals visiting outpatient clinics of nephrology, GIT and internal medicine in Assiut hospitals.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of medicine Assiut university
Asyut
Rehab Mohamed Mohamed Eltayeb Ahmed, M.B.B.CH., 01016644593, rehab.eltaib@med.aun.edu.eg
About this study
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.
Read the detailed 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.
- Conditions
- CKD, Gall Bladder Dysfunction
- Being tested
- abdominal ultrasonography.
- Keywords
- CKD, gall bladder dysfunction, gall bladder ejection fraction, hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal ultrasonography.Diagnostic test
Evaluate the gallbladder ejection fraction (EF)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Gallbladder dysfunction in pre-dialysis CKD patients. Receives: Diagnostic Test: abdominal ultrasonography. | |
| Group II | Gallbladder dysfunction in end stage CKD patients on dialysis. Receives: Diagnostic Test: abdominal ultrasonography. | |
| Control Group | Gallbladder dysfunction in normal renal function participants (control group). Receives: Diagnostic Test: abdominal ultrasonography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: measuring fasting gallbladder volume (FV) after 10 overnight hours fasting and the residual gallbladder volume (RV) after 30 minutes after standard fixed meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab Mohamed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437418
- Sponsor's protocol ID
- Gallbladder dysfunction in CKD
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors
- ClinicalTrials.gov ID
- NCT06437418
- Acronym / sponsor ID
- Gallbladder dysfunction in CKD
- Conditions
- CKD, Gall Bladder Dysfunction
- Keywords
- CKD, gall bladder dysfunction, gall bladder ejection fraction, hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: abdominal ultrasonography.Gallbladder dysfunction in pre-dialysis CKD patients. |
| Group II | – | Diagnostic Test: abdominal ultrasonography.Gallbladder dysfunction in end stage CKD patients on dialysis. |
| Control Group | – | Diagnostic Test: abdominal ultrasonography.Gallbladder dysfunction in normal renal function participants (control group). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- individuals visiting outpatient clinics of nephrology, GIT and internal medicine in Assiut hospitals.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal ultrasonography.Evaluate the gallbladder ejection fraction (EF) | Diagnostic test | Control Group, Group I, Group II |
Primary outcome
Gallbladder dysfunction in CKD patients
Time frame: measuring fasting gallbladder volume (FV) after 10 overnight hours fasting and the residual gallbladder volume (RV) after 30 minutes after standard fixed meal
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and Gall Bladder Dysfunction, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rehab Mohamed Mohamed Eltayeb, M.B.B.CH. (01016644593, rehab.eltaib@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gallbladder dysfunction in CKD patients (time frame: measuring fasting gallbladder volume (FV) after 10 overnight hours fasting and the residual gallbladder volume (RV) after 30 minutes after standard fixed meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.