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Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital

Primary Purpose

Chronic Renal Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyroid function tests
complete blood count
serum creatinine
blood urea
serum electrolyte
serum calcium
serum phosphorus
parathyroid hormone level
liver function test
arterial blood gases
complete urine analysis
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Renal Failure

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pediatric group

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 20, 2022
    Last Updated
    July 6, 2022
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05451472
    Brief Title
    Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital
    Official Title
    Evalution of Thyroid Functions in Hemodialysis Children in Sohag University Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    January 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Renal Failure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pediatric group
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    thyroid function tests
    Intervention Description
    Thyroid function tests:thyroid stimulating hormone (TSH), total thyroxine (T4), free thyroxine (FT4), total triiodothyronine (T3), and free triiodothyronine (FT3)
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    complete blood count
    Intervention Description
    complete blood count
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    serum creatinine
    Intervention Description
    serum creatinine
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    blood urea
    Intervention Description
    blood urea
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    serum electrolyte
    Intervention Description
    serum electrolyte
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    serum calcium
    Intervention Description
    serum calcium
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    serum phosphorus
    Intervention Description
    serum phosphorus
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    parathyroid hormone level
    Intervention Description
    parathyroid hormone level
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    liver function test
    Intervention Description
    ALT_AST_Total biliruin_total protein _serum albumin
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    arterial blood gases
    Intervention Description
    PH_PCO2_PO2_HCO3_base deficit
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    complete urine analysis
    Intervention Description
    complete urine analysis
    Primary Outcome Measure Information:
    Title
    Detection of thyroid function in hemodialysis childern
    Description
    Detection of decrease thyroid function(T3_T4_TSH) in hemodialysis childern Detection of increase thyroid function(T3_T4_TSH) in hemodialysis childern
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 .

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31013508
    Citation
    Pan B, Du X, Zhang H, Hua X, Wan X, Cao C. Relationships of Chronic Kidney Disease and Thyroid Dysfunction in Non-Dialysis Patients: A Pilot Study. Kidney Blood Press Res. 2019;44(2):170-178. doi: 10.1159/000499201. Epub 2019 Apr 23.
    Results Reference
    background
    PubMed Identifier
    30152421
    Citation
    Naseem F, Mannan A, Dhrolia MF, Imtiaz S, Qureshi R, Ahmed A. Prevalence of subclinical hypothyroidism in patients with chronic kidney disease on maintenance hemodialysis. Saudi J Kidney Dis Transpl. 2018 Jul-Aug;29(4):846-851. doi: 10.4103/1319-2442.239646.
    Results Reference
    background

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    Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital

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