Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital

July 6, 2022 updated by: Michael Rafat Helmi, Sohag University

Evalution of Thyroid Functions in Hemodialysis Children in Sohag University Hospital

Thyroid gland and its hormones play an important role in organ development and the homeostatic control of many physiological mechanisms such as body growth and energy expenditure. The two main thyroid hormones are triiodothyronine (T3) and thyroxine (T4) affect renal development and metabolism so any impairment in thyroid functions lead to or aggravate kidney diseases.

On the other hand, kidneys play an important role in the thyroid metabolism as it normally contributes to the clearance of iodide, primarily by glomerular filtration. Among patients with renal failure, there is diminished iodide excretion and an increase in plasma inorganic iodide, which results in increased uptake of the iodide by the thyroid gland. Increases in total body inorganic iodide can potentially block thyroid hormone production (the Wolff-Chaik off effect). Such a change may explain the slightly higher frequency of goiter and hypothyroidism in patients with chronic kidney diseases.

The kidneys affect the hypothalamic pituitary-thyroid axis, so any impairment in kidney functions leads to disturbed thyroid physiology. All levels of the hypothalamic-pituitary-thyroid axis may be involved, including alterations in hormone production, distribution, and excretion.

End stage renal disease (ESRD) and hemodialysis (HD) affect the levels of all thyroid hormones. The earliest and the most common thyroid function abnormality in patients with ESRD on HD is low T3 level (especially total T3 than free T3). This is called 'low T3 syndrome. The prevalence of subclinical hypothyroidism has been reported to be much higher in patients with ESRD on HD than in the general population.

Due to similarity of signs and symptoms, sometimes it is difficult to identify subjects with ESRD also has hypothyroidism; therefore, different studies have been carried out to establish the incidence of these conditions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Not Applicable

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

2 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children started hemodialysis for end stage renal disease at age of 2 to 16 years will be included in the study.

Exclusion Criteria:

  • Patients with known thyroid disease. Patients with a history of autoimmune disease .

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: pediatric group
Diagnostic test: complete blood count
complete blood count
Diagnostic test: thyroid function tests
Thyroid function tests:thyroid stimulating hormone (TSH), total thyroxine (T4), free thyroxine (FT4), total triiodothyronine (T3), and free triiodothyronine (FT3)
Diagnostic test: serum creatinine
serum creatinine
Diagnostic test: blood urea
blood urea
Diagnostic test: serum electrolyte
serum electrolyte
Diagnostic test: serum calcium
serum calcium
Diagnostic test: serum phosphorus
serum phosphorus
Diagnostic test: parathyroid hormone level
parathyroid hormone level
Diagnostic test: liver function test
ALT_AST_Total biliruin_total protein _serum albumin
Diagnostic test: arterial blood gases
PH_PCO2_PO2_HCO3_base deficit
Diagnostic test: complete urine analysis
complete urine analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of thyroid function in hemodialysis childern
Time Frame: 6 months
Detection of decrease thyroid function(T3_T4_TSH) in hemodialysis childern Detection of increase thyroid function(T3_T4_TSH) in hemodialysis childern
6 months

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)

July 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (ACTUAL)

July 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-22-06-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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