Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital

NCT ID: NCT05451472

Last Updated: 2022-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Renal Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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pediatric group

Group Type EXPERIMENTAL

thyroid function tests

Intervention Type DIAGNOSTIC_TEST

Thyroid function tests:thyroid stimulating hormone (TSH), total thyroxine (T4), free thyroxine (FT4), total triiodothyronine (T3), and free triiodothyronine (FT3)

complete blood count

Intervention Type DIAGNOSTIC_TEST

complete blood count

serum creatinine

Intervention Type DIAGNOSTIC_TEST

serum creatinine

blood urea

Intervention Type DIAGNOSTIC_TEST

blood urea

serum electrolyte

Intervention Type DIAGNOSTIC_TEST

serum electrolyte

serum calcium

Intervention Type DIAGNOSTIC_TEST

serum calcium

serum phosphorus

Intervention Type DIAGNOSTIC_TEST

serum phosphorus

parathyroid hormone level

Intervention Type DIAGNOSTIC_TEST

parathyroid hormone level

liver function test

Intervention Type DIAGNOSTIC_TEST

ALT\_AST\_Total biliruin\_total protein \_serum albumin

arterial blood gases

Intervention Type DIAGNOSTIC_TEST

PH\_PCO2\_PO2\_HCO3\_base deficit

complete urine analysis

Intervention Type DIAGNOSTIC_TEST

complete urine analysis

Interventions

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thyroid function tests

Thyroid function tests:thyroid stimulating hormone (TSH), total thyroxine (T4), free thyroxine (FT4), total triiodothyronine (T3), and free triiodothyronine (FT3)

Intervention Type DIAGNOSTIC_TEST

complete blood count

complete blood count

Intervention Type DIAGNOSTIC_TEST

serum creatinine

serum creatinine

Intervention Type DIAGNOSTIC_TEST

blood urea

blood urea

Intervention Type DIAGNOSTIC_TEST

serum electrolyte

serum electrolyte

Intervention Type DIAGNOSTIC_TEST

serum calcium

serum calcium

Intervention Type DIAGNOSTIC_TEST

serum phosphorus

serum phosphorus

Intervention Type DIAGNOSTIC_TEST

parathyroid hormone level

parathyroid hormone level

Intervention Type DIAGNOSTIC_TEST

liver function test

ALT\_AST\_Total biliruin\_total protein \_serum albumin

Intervention Type DIAGNOSTIC_TEST

arterial blood gases

PH\_PCO2\_PO2\_HCO3\_base deficit

Intervention Type DIAGNOSTIC_TEST

complete urine analysis

complete urine analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 .
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Michael Rafat Helmi

resident doctor at pediatric department

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 31013508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30152421 (View on PubMed)

Other Identifiers

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soh-22-06-09

Identifier Type: -

Identifier Source: org_study_id

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