NCT06437418

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 26, 2024

Last Update Submit

May 30, 2024

Conditions

CKDGall Bladder Dysfunction

Keywords

CKDgall bladder dysfunctiongall bladder ejection fractionhemodialysis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group I

Gallbladder dysfunction in pre-dialysis CKD patients.

Diagnostic Test: abdominal ultrasonography.

Group II

Gallbladder dysfunction in end stage CKD patients on dialysis.

Diagnostic Test: abdominal ultrasonography.

Control Group

Gallbladder dysfunction in normal renal function participants (control group).

Diagnostic Test: abdominal ultrasonography.

Interventions

abdominal ultrasonography.DIAGNOSTIC_TEST

Evaluate the gallbladder ejection fraction (EF)

Control GroupGroup IGroup II

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

individuals visiting outpatient clinics of nephrology, GIT and internal medicine in Assiut hospitals.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Assiut university

Asyut, Egypt

Location

Central Study Contacts

Rehab Mohamed Mohamed Eltayeb, M.B.B.CH.

CONTACT

01016644593rehab.eltaib@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

May 26, 2024

First Posted

May 31, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations

EG(1)