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

NCT06500663 | Not Yet Recruiting DMC

• 2 other identifiers: DR.sahar protocolfaculty
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.Study the effects of frequent haemodialysis on thyroid function

Conditions

Haemodialysis Patients

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 year

Study Arms (1)

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

Interventions

haemodialysis OTHER

haemodialysis effect on thyroid function

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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% .

You may qualify if:

• 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).

You may not qualify if:

• \- 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).
• \. 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

Sponsors & Collaborators

• Sahar Ezeldeen Hussein Ali: lead
• Assiut University: collaborator

Related Publications (6)

• 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.

  PMID: 15698444 BACKGROUND

• Kaptein 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.

  PMID: 3259281 BACKGROUND

• Lim 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.

  PMID: 11576928 BACKGROUND

• Schultheiss 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.

  PMID: 34349984 BACKGROUND

• Sanai 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.

  PMID: 33524972 BACKGROUND

• Rhee 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.

  PMID: 28324018 BACKGROUND

MeSH Terms

Interventions

Dialysis

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assuit

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: August 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-07