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

ConditionHaemodialysis Patients

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorSahar Ezeldeen Hussein Ali

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

None

Trial 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% .

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

haemodialysis
Other intervention
haemodialysis effect on thyroid function

Treatment groups

160 Participants

are divided into 1 treatment group

Group A: 11 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame

1 year

Secondary outcomes

1. Correlation of TSH Concentrations with Age: A secondary outcome measure could be the correlation of TSH concentrations with age.

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.

Time frame

1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahar Ezeldeen Hussein Ali

Lead sponsor

Assiut University

Sponsor institution