Clincosm LogoSign in Get a demo

Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05451472
Collaborator
(none)
39
Enrollment
1
Arm
6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: thyroid function tests
  • Diagnostic Test: complete blood count
  • Diagnostic Test: serum creatinine
  • Diagnostic Test: blood urea
  • Diagnostic Test: serum electrolyte
  • Diagnostic Test: serum calcium
  • Diagnostic Test: serum phosphorus
  • Diagnostic Test: parathyroid hormone level
  • Diagnostic Test: liver function test
  • Diagnostic Test: arterial blood gases
  • Diagnostic Test: complete urine analysis
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evalution of Thyroid Functions in Hemodialysis Children in Sohag University Hospital
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: pediatric group

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: complete blood count
complete blood count

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

Outcome Measures

Primary Outcome Measures

  1. Detection of thyroid function in hemodialysis childern [6 months]

    Detection of decrease thyroid function(T3_T4_TSH) in hemodialysis childern Detection of increase thyroid function(T3_T4_TSH) in hemodialysis childern

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Michael Rafat Helmi, resident doctor at pediatric department, Sohag University
ClinicalTrials.gov Identifier:
NCT05451472
Other Study ID Numbers:
  • soh-22-06-09
First Posted:
Jul 11, 2022
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Failure, Chronic
Calcium
Parathyroid Hormone
Hormones

Study Results

No Results Posted as of Jul 11, 2022