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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06104046
Other study ID # seroconversion of hepatitis c
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 26, 2023
Est. completion date March 31, 2025

Study information

Verified date October 2023
Source Assiut University
Contact Mahmoud Mohamed Zeawela
Phone 01098359166
Email mahmoudz3wela777@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

observational cross sectional study for children with chronic kidney disease who on regular hemodialysis in assiut univeristy children hospital at dialysis unit, observe prevalence of serological seroconversion of hepatitis c virus and associated risk factors


Description:

Hepatitis C virus (HCV) is a blood-borne pathogen that appears to be endemic in many parts of the world,the highest prevalence of HCV has been found in Egypt (17-26%) The prevalence of HCV infection is higher in most subgroups of chronic kidney disease (CKD) patients than in the general population. As there is very little known about HCV infection in infants and children with CKD and this very limited information implies that the current guidelines do not apply directly and completely to this specific population, and as the Kidney Disease Improving Global Outcomes (KDIGO) has recommended that pediatric nephrologists and other physicians - in charge of caring for children with CKD - should carefully evaluate the extent to which the current guidelines may be extrapolated to children. Hepatitis C virus (HCV) infection is a significant cause of morbidity and mortality in hemodialysis patients and observed as a major public health problem infecting 170 million people globally and hepatitis C virus (HCV) infection is one of the most common blood-borne infections in Egypt, a large number of egyptians are exposed to infection due to low hygiene and sterilization measures in our community The Patients who undergo maintenance hemodialysis (HD) treatment are at increased hazard of getting these infections and have a greater prevalence of HCV than the general population due to underlying impaired cellular immunity which increases their susceptibility to HCV infection the hemodialysis patients are exposed to prolonged vascular access and exposure to contaminated equipment and handling by medical staff, In addition the CKD patients require frequent blood transfusion to recover the anemia related with chronic kidney disease and this blood transfusion make a source for HCV infection The inadequate sterilization of medical equipments, invasive dialysis procedures, mode of dialysis, contaminated blood and blood products, duration of end stage kidney disease, sharing of dialysis equipment, insertion of an intravascular catheter and contact with contaminated HD equipments and supplies during hemodialysis, all these risk factors help in HCV infection in hemodialysis patients. In this study, the prevalence of seroconversion of hepatitis c virus among children with CKD on regular hemodialysis is to be assessed and its possible risk factors related to it


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date March 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria: 1. Age: from 1 year to 18 years 2. CKD children on regular hemodialysis for more than one month duration Exclusion Criteria: - 1-Age: less than 1 year and more than 18 years 2- CKD children who are not on regular hemodialysis and for less than one month duration

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

El-Shabrawi MH, Kamal NM. Burden of pediatric hepatitis C. World J Gastroenterol. 2013 Nov 28;19(44):7880-8. doi: 10.3748/wjg.v19.i44.7880. — View Citation

Kosaraju K, Faujdar SS, Singh A, Prabhu R. Hepatitis viruses in heamodialysis patients: an added insult to injury? Hepat Res Treat. 2013;2013:860514. doi: 10.1155/2013/860514. Epub 2013 Mar 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis determine prevalence and risk factors associated with seroconversion of hepatitis c in CKD children on regular hemodialysis Baseline
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