Clinical trial NCT07022236: Assessment of Thyroid Dysfunction in Patients Undergoing Haemodialysis at Sohag University Hospital
Official title: Assessment of Thyroid Dysfunction in Patients Undergoing Haemodialysis at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dialysis; Complications
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 1
Sex: ALL
Minimum age (years): 13
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing hemodialysis in sohag university hospital

Brief summary: Thyroid dysfunction is a prevalent endocrine disorder that significantly impacts the health of patients with chronic kidney disease (CKD), particularly those undergoing dialysis. The prevalence of thyroid dysfunction in dialysis patients has been reported to range from 20% to 60%, highlighting the need for routine screening and management in this vulnerable group (Kuo et al., 2024). Thyroid hormones play a crucial role in regulating various physiological processes, and their dysregulation can lead to complications such as cardiovascular disease, anemia, and impaired quality of life, which are particularly concerning in the dialysis population (Smith et al., 2024).

The relationship between CKD and thyroid dysfunction is complex and multifactorial. Uremic toxins can interfere with the hypothalamic-pituitary-thyroid axis, leading to alterations in thyroid hormone production and metabolism. Recent studies have shown that inflammation and oxidative stress associated with CKD can further exacerbate thyroid dysfunction (Johnson et al., 2024). Understanding these mechanisms is essential for developing effective management strategies for thyroid health in dialysis patients.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older.
* Patients diagnosed with end-stage renal disease (ESRD) on regular hemodialysis for at least 3 months.

Exclusion Criteria:

* Known Thyroid Disorders: Patients with a history of thyroid disease (e.g., hypothyroidism, hyperthyroidism) prior to starting dialysis.
* Recent Thyroid Treatment: Patients who have received treatment for thyroid dysfunction (e.g., thyroid hormone replacement, antithyroid medications) within the last six months.
* Patients with acute kidney injury (AKI) or those who are not on regular dialysis.
* Pregnant or lactating women.
* Patients with systemic illnesses or medications that could interfere with thyroid function tests (e.g., corticosteroids, lithium).

Primary outcomes:
measure: Number of Participants With Thyroid Dysfunction Diagnosed by Serum TSH, Free T3, and Free T4 Levels
timeFrame: Up to 6 months from enrollment
Secondary outcomes:
measure: Number of Participants With Thyroid Dysfunction Stratified by Dialysis Duration and Ultrafiltration Rate
timeFrame: Up to 6 months from enrollment
Other outcomes:
measure: Number of Participants With Thyroid Dysfunction by Underlying Cause of Kidney Disease
timeFrame: Up to 6 months from enrollment
Locations:
city: Sohag
country: Egypt
facility: Hospital
Study officials:
References: