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
About this trial
This is an interventional diagnostic trial for Chronic Renal Failure
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 .
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
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
Learn more about this trial
Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital
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