Dialysis; ComplicationsNCT07022236
Assessment of Thyroid Dysfunction in Patients Undergoing Haemodialysis at Sohag University Hospital
An observational study of Dialysis; Complications, run by Sohag University at 1 site in Egypt.
Trial summary
Thyroid dysfunction is a prevalent endocrine disorder that significantly impacts the health of patients with chronic kidney disease (CKD), particularly those undergoing dialysis. Read more about this study
- Who is it for?
- Ages 13 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dialysis; Complications
- What is being tested?
- Thyroid profile
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Apr 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients undergoing hemodialysis in sohag university hospital
Who may be able to join
- Adults aged 18 years and older.
- Patients diagnosed with end-stage renal disease (ESRD) on regular hemodialysis for at least 3 months.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Hospital
Sohag
Sohag University Hospital Sohag, 0932222222, contact@sohag.univ.gov
About this study
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.
- Conditions
- Dialysis; Complications
- Being tested
- Thyroid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid profileDiagnostic test
Thyroid dysfunction in patients undergoing hemogdialysis in sohag university hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months from enrollment
Secondary outcomes (1)
Number of Participants With Thyroid Dysfunction Stratified by Dialysis Duration and Ultrafiltration Rate
Number of Participants With Thyroid Dysfunction Stratified by Dialysis Duration and Ultrafiltration Rate Dialysis duration recorded in months Ultrafiltration rate recorded in mL/kg/hour Thyroid dysfunction diagnosed by TSH, free T3, and free T4 levels
Measured: Up to 6 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start13 Apr 2025
- Primary completion13 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022236
- Sponsor's protocol ID
- Soh-Med--25-4-012MS
- Status last verified
- Jun 2025
- First submitted
- 24 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Thyroid Dysfunction in Patients Undergoing Haemodialysis at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT07022236
- Acronym / sponsor ID
- Soh-Med--25-4-012MS
- Conditions
- Dialysis; Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Apr 2025 (actual)
- Primary completion
- 13 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing hemodialysis in sohag university hospital
Key inclusion criteria (2 listed)
- Adults aged 18 years and older.
- Patients diagnosed with end-stage renal disease (ESRD) on regular hemodialysis for at least 3 months.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid profileThyroid dysfunction in patients undergoing hemogdialysis in sohag university hospital | Diagnostic test | – |
Primary outcome
Number of Participants With Thyroid Dysfunction Diagnosed by Serum TSH, Free T3, and Free T4 Levels
Time frame: Up to 6 months from enrollment
Diagnosis will be classified as: Hypothyroidism Subclinical hypothyroidism Hyperthyroidism
1 secondary outcome
Number of Participants With Thyroid Dysfunction Stratified by Dialysis Duration and Ultrafiltration Rate
Time frame: Up to 6 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis; Complications, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Thyroid Dysfunction Diagnosed by Serum TSH, Free T3, and Free T4 Levels (time frame: Up to 6 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.