Studying Thyroid Function of Haemodialysis Patients in Upper Egypt (Two Centers Study).

July 8, 2024 updated by: Sahar Ezeldeen Hussein Ali
  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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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% .

Description

Inclusion Criteria:

  1. Patients who have been on hemodialysis for at least 6 months.
  2. Patients aged between 18 and 75 years
  3. Patients without overt hyper/hypothyroidism or thyroid hormone supplementation (for examining endogenous thyroid function).

Exclusion Criteria:

- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
patients on haemodialysis themselves and their hospital records including the participant's information (name, age, sex, admission date, clinical procedures, medications administered…etc).
Other: haemodialysis
haemodialysis effect on thyroid function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Correlation of TSH Concentrations with Age: A secondary outcome measure could be the correlation of TSH concentrations with age.
Time Frame: 1 year

2. 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.

3. 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahar Ezeldeen Hussein Ali

Collaborators

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DR.sahar protocol
  • faculty (Other Identifier: of medicine Assuit university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

  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..

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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