Factors Predicting Erythropoietin Responsiveness in Children on Hemodialysis at Sohag University Hospital

March 28, 2022 updated by: Hanan Nagdy Fawzy, Sohag University

University Hospital

Anemia is common in patients on hemodialysis (HD) due to lack of erythropoietin (EPO) synthesis and iron deficiency is occurring in HD patients due to chronic blood loss through the dialysis circuit, repeated blood sampling, shortened red blood cell life span and lack of adherence to treatment .

Anemia is one of the most important complications that affects morbidity and mortality in chronic kidney disease (CKD) patients. It has significant impacts on those patients such as fatigue, weakness, shortness of breath, decreased quality of life, exercise capacity and physical activity, growth retardation and decreased cognitive functions, left ventricular hypertrophy, and congestive heart failure So, proper management of anemia is very important .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

These children are attending in our Pediatric dialysis unit at Sohag University Hospital, Egypt between April 2022 and April 2023.

Description

Inclusion Criteria:

  • (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on regular hemodialysis.

Exclusion Criteria:

  • Children who have no other co existent hematological disorder .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
responsiveness to erythropoietin stimulating agent
we evolute responsiveness of patients on hemodialysis for erythropoietin stimulating agents or not and factors effecting this response
Diagnostic test: seum zinic,vit B12, parathyriod function
seum zinic,vit B12, parathyriod function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hb g/dl
Time Frame: one year
measure hemoglobin level
one year
Iron profile
Time Frame: one year
measure iron profile on blood
one year
Serum creatinine
Time Frame: one year
serum creatinine
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-03-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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