Haemodialysis PatientsNCT06500663
Studying Thyroid Function of Haemodialysis Patients in Upper Egypt (Two Centers Study).
An observational study of Haemodialysis Patients, run by Sahar Ezeldeen Hussein Ali.
Trial summary
1. The study aims to investigate the prevalence of thyroid dysfunction in haemodialysis patients and study the association of thyroid hormone concentration with health status of those patients 2. Study the effects of frequent haemodialysis on thyroid function Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Haemodialysis Patients
- What is being tested?
- haemodialysis
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Dec 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: based on determining the main outcome variable, The estimated minimum required sample size is 160 patients. The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is which is to investigate the prevalence of thyroid disfunction in haemodialysis patients and the association of thyroid hormone concentration with health status of those patients Based on previous studies (Lo et al., 2017) the prevalence of thyroid disfunction in haemodialysis patients was 21.8% , and based on the percentage confidence limits of 4% and a Confidence level =80% .
Who may be able to join
- Patients who have been on hemodialysis for at least 6 months.
- Patients aged between 18 and 75 years
- Patients without overt hyper/hypothyroidism or thyroid hormone supplementation (for examining endogenous thyroid function).
Who cannot join
- 4. Patients with a history of thyroid disease or thyroid surgery. 5. Patients currently on medications known to affect thyroid function (e.g., amiodarone, lithium).
- 6. Pregnant or breastfeeding women. 7. Patients with other serious illnesses (e.g., cancer, severe heart disease) that could affect thyroid function or the ability to participate in the study 8. Patients receiving thyroid hormone supplementation
About this study
- The study aims to investigate the prevalence of thyroid dysfunction in haemodialysis patients and study the association of thyroid hormone concentration with health status of those patients
- Study the effects of frequent haemodialysis on thyroid function
Read the detailed description
2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) The study of thyroid function in hemodialysis patients is a critical area of research due to the complex interplay between renal failure and thyroid pathology. Chronic kidney disease (CKD) and end-stage renal disease (ESRD) have been associated with various thyroid abnormalities, including hypothyroidism and low triiodothyronine (T3) syndrome (1). These conditions can significantly impact the morbidity and mortality of patients undergoing hemodialysis (2).
In hemodialysis patients, the prevalence of thyroid dysfunction is higher compared to the general population(3). This is partly due to the altered metabolism and clearance of thyroid hormones and the impact of uremic toxins on thyroid function (4). Moreover, thyroid hormones play a crucial role in cardiovascular health, which is of particular concern in hemodialysis patients who are already at an increased risk for cardiovascular events (5).
Recent studies have shown that even subclinical hypothyroidism, where patients have an elevated thyroid-stimulating hormone (TSH) level but normal thyroxine (T4) levels, can be associated with adverse outcomes in hemodialysis patients (6). This condition may contribute to an increased risk of cardiovascular disease and mortality (7).
The assessment of thyroid function in hemodialysis patients typically involves measuring serum levels of TSH, free T4, and T3 (8). However, interpreting these levels can be challenging due to the effects of medications, nutritional status, and non-thyroidal illness on the thyroid axis (9). It is also important to consider the impact of hemodilution on thyroid function tests, as it can lead to misinterpretation of the results (10).
Management of thyroid dysfunction in hemodialysis patients requires careful consideration. While thyroid hormone replacement therapy is commonly used to treat hypothyroidism, the optimal target levels of TSH and T4 in this population are still under investigation (11). Additionally, the benefits of treating subclinical hypothyroidism in hemodialysis patients remain uncertain (12).
In the context of Egypt, the prevalence of thyroid dysfunction among hemodialysis patients mirrors global trends. A study conducted in a South Indian cohort, which may have parallels in Egypt due to similar dietary and environmental factors, found a high prevalence of subclinical hypothyroidism in hemodialysis patients(13). This suggests that thyroid screening and management should be an integral part of care for hemodialysis patients in Egypt as well.
Egypt's healthcare system has been making strides in improving the management of chronic diseases, including CKD and its complications. With a growing focus on preventive care and early intervention, the management of thyroid dysfunction in hemodialysis patients is likely to receive more attention in the coming years (14).
In Upper Egypt, research has been conducted to investigate the prevalence and nature of thyroid abnormalities among hemodialysis patients. A cross-sectional observational report enrolled 160 subjects at Al-Hussein Hospital, Al-Azhar University, and the National Institute of Nephrology and Urology, revealing significant correlations between thyroid hormones and various clinical parameters (15). Another study assessed thyroid hormone levels in 200 patients with chronic renal failure undergoing maintenance hemodialysis, finding a high prevalence of thyroid hormone dysfunction even in clinically euthyroid patients(16).
In conclusion, the study of thyroid function in hemodialysis patients is essential for optimizing patient outcomes. With ongoing research and improved clinical practices, the management of thyroid dysfunction in this vulnerable population can be enhanced. As Egypt continues to develop its healthcare infrastructure, it is poised to make significant contributions to this field of study (17).
- Conditions
- Haemodialysis Patients
- Being tested
- haemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
haemodialysisOther
haemodialysis effect on thyroid function
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients on haemodialysis themselves and their hospital records including the participant's information (name, age, sex, admission date, clinical procedures, medications administered…etc). Receives: Other: haemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Prevalence of Hypothyroidism: The primary outcome measure could be the prevalence of hypothyroidism in patients with end-stage renal disease (ESRD) undergoing frequent hemodialysis
- Changes in Thyroid Hormone Levels: Another primary outcome measure could be the changes in serum TSH, free thyroxine (FT4), and free triiodothyronine (FT3) concentrations in patients undergoing frequent hemodialysis.
Measured: 1 year
Secondary outcomes (1)
1. Correlation of TSH Concentrations with Age: A secondary outcome measure could be the correlation of TSH concentrations with age.
- Association of Thyroid Hormone Levels with Health Status: the association of circulating thyroid hormone levels with parameters of self-reported health status, and physical and cognitive performance.
- Effects of Increased Dialysis Frequency on Thyroid Indices: The effects of increased dialysis frequency on thyroid indices in patients receiving haemodialysis without overt hyper/hypothyroidism or thyroid hormone treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Haemodialysis PatientsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahar Ezeldeen Hussein Ali
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Sahar Ezeldeen Hussein Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500663
- Sponsor's protocol ID
- DR.sahar protocol
- Other IDs
- faculty
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 1. The study aims to investigate the prevalence of thyroid dysfunction in haemodialysis patients and study the association of thyroid hormone concentration with health status of those patients 2. Study the effects of frequent haemodialysis on thyroid function..
Publications
Lo JC, Chertow GM, Go AS, Hsu CY. Increased prevalence of subclinical and clinical hypothyroidism in persons with chronic kidney disease. Kidney Int. 2005 Mar;67(3):1047-52. doi: 10.1111/j.1523-1755.2005.00169.x.
PubMed 15698444Kaptein EM, Quion-Verde H, Chooljian CJ, Tang WW, Friedman PE, Rodriquez HJ, Massry SG. The thyroid in end-stage renal disease. Medicine (Baltimore). 1988 May;67(3):187-97. doi: 10.1097/00005792-198805000-00005.
PubMed 3259281Lim VS. Thyroid function in patients with chronic renal failure. Am J Kidney Dis. 2001 Oct;38(4 Suppl 1):S80-4. doi: 10.1053/ajkd.2001.27410.
PubMed 11576928Schultheiss UT, Steinbrenner I, Nauck M, Schneider MP, Kotsis F, Baid-Agrawal S, Schaeffner E, Eckardt KU, Kottgen A, Sekula P; GCKD investigators. Thyroid function, renal events and mortality in chronic kidney disease patients: the German Chronic Kidney Disease study. Clin Kidney J. 2020 Jun 4;14(3):959-968. doi: 10.1093/ckj/sfaa052. eCollection 2021 Mar.
PubMed 34349984Sanai T, Okamura K, Onoue T, Ono T, Motomura K, Miyazono M, Shimamatsu K. Hemodilution Impacts Assessment of Thyroid Status before and after Hemodialysis in Patients with End-Stage Renal Disease. Am J Nephrol. 2021 Feb 1;51(12):988-994. doi: 10.1159/000512968. Online ahead of print.
PubMed 33524972Rhee CM, You AS, Nguyen DV, Brunelli SM, Budoff MJ, Streja E, Nakata T, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Status and Mortality in a Prospective Hemodialysis Cohort. J Clin Endocrinol Metab. 2017 May 1;102(5):1568-1577. doi: 10.1210/jc.2016-3616.
PubMed 28324018
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Thyroid Function of Haemodialysis Patients in Upper Egypt (Two Centers Study).
- ClinicalTrials.gov ID
- NCT06500663
- Acronym / sponsor ID
- DR.sahar protocol
- Conditions
- Haemodialysis Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sahar Ezeldeen Hussein AliUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jul 2024 (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.
- The study aims to investigate the prevalence of thyroid dysfunction in haemodialysis patients and study the association of thyroid hormone concentration with health status of those patients
- Study the effects of frequent haemodialysis on thyroid function
Detailed description
2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) The study of thyroid function in hemodialysis patients is a critical area of research due to the complex interplay between renal failure and thyroid pathology. Chronic kidney disease (CKD) and end-stage renal disease (ESRD) have been associated with various thyroid abnormalities, including hypothyroidism and low triiodothyronine (T3) syndrome (1). These conditions can significantly impact the morbidity and mortality of patients undergoing hemodialysis (2).
In hemodialysis patients, the prevalence of thyroid dysfunction is higher compared to the general population(3). This is partly due to the altered metabolism and clearance of thyroid hormones and the impact of uremic toxins on thyroid function (4). Moreover, thyroid hormones play a crucial role in cardiovascular health, which is of particular concern in hemodialysis patients who are already at an increased risk for cardiovascular events (5).
Recent studies have shown that even subclinical hypothyroidism, where patients have an elevated thyroid-stimulating hormone (TSH) level but normal thyroxine (T4) levels, can be associated with adverse outcomes in hemodialysis patients (6). This condition may contribute to an increased risk of cardiovascular disease and mortality (7).
The assessment of thyroid function in hemodialysis patients typically involves measuring serum levels of TSH, free T4, and T3 (8). However, interpreting these levels can be challenging due to the effects of medications, nutritional status, and non-thyroidal illness on the thyroid axis (9). It is also important to consider the impact of hemodilution on thyroid function tests, as it can lead to misinterpretation of the results (10).
Management of thyroid dysfunction in hemodialysis patients requires careful consideration. While thyroid hormone replacement therapy is commonly used to treat hypothyroidism, the optimal target levels of TSH and T4 in this population are still under investigation (11). Additionally, the benefits of treating subclinical hypothyroidism in hemodialysis patients remain uncertain (12).
In the context of Egypt, the prevalence of thyroid dysfunction among hemodialysis patients mirrors global trends. A study conducted in a South Indian cohort, which may have parallels in Egypt due to similar dietary and environmental factors, found a high prevalence of subclinical hypothyroidism in hemodialysis patients(13). This suggests that thyroid screening and management should be an integral part of care for hemodialysis patients in Egypt as well.
Egypt's healthcare system has been making strides in improving the management of chronic diseases, including CKD and its complications. With a growing focus on preventive care and early intervention, the management of thyroid dysfunction in hemodialysis patients is likely to receive more attention in the coming years (14).
In Upper Egypt, research has been conducted to investigate the prevalence and nature of thyroid abnormalities among hemodialysis patients. A cross-sectional observational report enrolled 160 subjects at Al-Hussein Hospital, Al-Azhar University, and the National Institute of Nephrology and Urology, revealing significant correlations between thyroid hormones and various clinical parameters (15). Another study assessed thyroid hormone levels in 200 patients with chronic renal failure undergoing maintenance hemodialysis, finding a high prevalence of thyroid hormone dysfunction even in clinically euthyroid patients(16).
In conclusion, the study of thyroid function in hemodialysis patients is essential for optimizing patient outcomes. With ongoing research and improved clinical practices, the management of thyroid dysfunction in this vulnerable population can be enhanced. As Egypt continues to develop its healthcare infrastructure, it is poised to make significant contributions to this field of study (17).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: haemodialysispatients on haemodialysis themselves and their hospital records including the participant's information (name, age, sex, admission date, clinical procedures, medications administered…etc). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- based on determining the main outcome variable, The estimated minimum required sample size is 160 patients. The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is which is to investigate the prevalence of thyroid disfunction in haemodialysis patients and the association of thyroid hormone concentration with health status of those patients Based on previous studies (Lo et al., 2017) the prevalence of thyroid disfunction in haemodialysis patients was 21.8% , and based on the percentage confidence limits of 4% and a Confidence level =80% .
Key inclusion criteria (3 listed)
- Patients who have been on hemodialysis for at least 6 months.
- Patients aged between 18 and 75 years
- Patients without overt hyper/hypothyroidism or thyroid hormone supplementation (for examining endogenous thyroid function).
Key exclusion criteria (2 listed)
- 4. Patients with a history of thyroid disease or thyroid surgery. 5. Patients currently on medications known to affect thyroid function (e.g., amiodarone, lithium).
- 6. Pregnant or breastfeeding women. 7. Patients with other serious illnesses (e.g., cancer, severe heart disease) that could affect thyroid function or the ability to participate in the study 8. Patients receiving thyroid hormone supplementation
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 |
|---|---|---|
| haemodialysishaemodialysis effect on thyroid function | Other | 1 |
Primary outcome
1. Prevalence of Hypothyroidism: The primary outcome measure could be the prevalence of hypothyroidism in patients with end-stage renal disease (ESRD) undergoing frequent hemodialysis
Time frame: 1 year
2. Changes in Thyroid Hormone Levels: Another primary outcome measure could be the changes in serum TSH, free thyroxine (FT4), and free triiodothyronine (FT3) concentrations in patients undergoing frequent hemodialysis.
1 secondary outcome
1. Correlation of TSH Concentrations with Age: A secondary outcome measure could be the correlation of TSH concentrations with age.
Time frame: 1 year
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 Jul 2024.
- Background: PubMed 15698444Lo JC, Chertow GM, Go AS, Hsu CY. Increased prevalence of subclinical and clinical hypothyroidism in persons with chronic kidney disease. Kidney Int. 2005 Mar;67(3):1047-52. doi: 10.1111/j.1523-1755.2005.00169.x.
- Background: PubMed 3259281Kaptein EM, Quion-Verde H, Chooljian CJ, Tang WW, Friedman PE, Rodriquez HJ, Massry SG. The thyroid in end-stage renal disease. Medicine (Baltimore). 1988 May;67(3):187-97. doi: 10.1097/00005792-198805000-00005.
- Background: PubMed 11576928Lim VS. Thyroid function in patients with chronic renal failure. Am J Kidney Dis. 2001 Oct;38(4 Suppl 1):S80-4. doi: 10.1053/ajkd.2001.27410.
- Background: PubMed 34349984Schultheiss UT, Steinbrenner I, Nauck M, Schneider MP, Kotsis F, Baid-Agrawal S, Schaeffner E, Eckardt KU, Kottgen A, Sekula P; GCKD investigators. Thyroid function, renal events and mortality in chronic kidney disease patients: the German Chronic Kidney Disease study. Clin Kidney J. 2020 Jun 4;14(3):959-968. doi: 10.1093/ckj/sfaa052. eCollection 2021 Mar.
- Background: PubMed 33524972Sanai T, Okamura K, Onoue T, Ono T, Motomura K, Miyazono M, Shimamatsu K. Hemodilution Impacts Assessment of Thyroid Status before and after Hemodialysis in Patients with End-Stage Renal Disease. Am J Nephrol. 2021 Feb 1;51(12):988-994. doi: 10.1159/000512968. Online ahead of print.
- Background: PubMed 28324018Rhee CM, You AS, Nguyen DV, Brunelli SM, Budoff MJ, Streja E, Nakata T, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Status and Mortality in a Prospective Hemodialysis Cohort. J Clin Endocrinol Metab. 2017 May 1;102(5):1568-1577. doi: 10.1210/jc.2016-3616.
- Individual participant dataSharing planned: Undecided. 1. The study aims to investigate the prevalence of thyroid dysfunction in haemodialysis patients and study the association of thyroid hormone concentration with health status of those patients 2. Study the effects of frequent haemodialysis on thyroid function..
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemodialysis Patients, run by Sahar Ezeldeen Hussein Ali.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Prevalence of Hypothyroidism: The primary outcome measure could be the prevalence of hypothyroidism in patients with end-stage renal disease (ESRD) undergoing frequent hemodialysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06500663, which also lists 6 linked publications.
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 Jul 2024.