NCT07022236

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 24, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

May 24, 2025

Last Update Submit

June 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Thyroid Dysfunction Diagnosed by Serum TSH, Free T3, and Free T4 Levels

    Diagnosis will be classified as: Hypothyroidism Subclinical hypothyroidism Hyperthyroidism

    Up to 6 months from enrollment

Secondary Outcomes (1)

  • Number of Participants With Thyroid Dysfunction Stratified by Dialysis Duration and Ultrafiltration Rate

    Up to 6 months from enrollment

Other Outcomes (1)

  • Number of Participants With Thyroid Dysfunction by Underlying Cause of Kidney Disease

    Up to 6 months from enrollment

Interventions

Thyroid profileDIAGNOSTIC_TEST

Thyroid dysfunction in patients undergoing hemogdialysis in sohag university hospital

Eligibility Criteria

Age13 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing hemodialysis in sohag university hospital

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital

Sohag, Egypt

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicine Resident

Study Record Dates

First Submitted

May 24, 2025

First Posted

June 15, 2025

Study Start

April 13, 2025

Primary Completion

October 13, 2025

Study Completion

October 30, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Locations