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Interleukin-6 and Thyroid Dysfunction in Hemodialysis Patients

Association Between Interleukin-6 and Thyroid Hormone Dysfunction in Patients With Chronic Kidney Disease Undergoing Hemodialysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07328113
Enrollment
65
Registered
2026-01-08
Start date
2023-11-14
Completion date
2024-06-30
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease on Hemodialysis, Thyroid Gland Disease

Keywords

Interleukin-6, Thyroid Function, Chronic Kidney Disease, Hemodialysis

Brief summary

Chronic kidney disease (CKD) is often associated with multiorgan complications, including thyroid hormone dysfunction. Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been proposed as a marker of inflammation that may contribute to these alterations. The main question it aims to answer is: Is there an association between interleukin-6 and thyroid hormone dysfunction in patients with chronic kidney disease (CKD) Blood samples will be collected and analyzed from 65 patients who have undergone hemodialysis for at least 3 months.

Detailed description

This cross-sectional observational study involves patients with CKD undergoing hemodialysis at Airlangga University Hospital. Data were collected based on their medical record and Blood test for IL-6. Linear regression analysis assessed the relationship between IL-6 levels and thyroid function parameters.

Interventions

DIAGNOSTIC_TESTThyroid hormone

Sampling was carried out using a consecutive sampling method, in which every patient who met the study criteria was included as a sample until the predetermined sample size was achieved. Patients who had been confirmed to meet the inclusion and exclusion criteria underwent blood collection of 10 mL (serum or plasma) prior to hemodialysis for the examination of complete blood count, BUN, creatinine, albumin, fasting blood glucose, IL-6, FT4, T3, FT3, T4, and TSH. The IL-6 level was measured using the Automatic Immunoassay Fluorescence method with the Automatic Fluorescence Immunoassay Analyzer Vazyme QD-S2000. Thyroid function tests (FT4, T3, T4, FT3, and TSH) were performed using the Enzyme-Linked Immunosorbent Assay (ELISA) method with Autobio Immunoassay reagents on the Autobio A1000 analyzer.

Sponsors

Universitas Airlangga Hospital, Surabaya
CollaboratorUNKNOWN
Dr. Soetomo General Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 21 Years Old and above * Patients with ESRD who have undergone hemodialysis for ≥ 3 months and are in stable condition. * Patients are able to communicate and respond to questions appropriately * Patients are willing to participate in the study.

Exclusion criteria

* ESRD patients undergoing hemodialysis who have been diagnosed with underlying thyroid disorders or thyroid malignancy. * Patients with a history of thyroid surgery or any intervention involving the thyroid gland. * Patients with a family history of thyroid disorders. * Patients taking medications that affect thyroid function or using antioxidant drugs. * Patients with infection or sepsis.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between serum Interleukin-6 (IL-6) concentration and serum Thyroid-Stimulating Hormone (TSH) levelsAt baseline, during routine hemodialysis visit (prior to any study-specific intervention)Serum IL-6 (pg/mL) and TSH (µIU/mL) will be measured using standardized hospital laboratory immunoassay analyzers. The outcome is the correlation coefficient (Spearman r) between IL-6 and TSH.

Secondary

MeasureTime frameDescription
Correlation between serum IL-6 concentration and serum Total Triiodothyronine (T3) levelsAt baseline, during routine hemodialysis visit (prior to any study-specific intervention)Both IL-6 (pg/mL) and T3 (ng/dL) will be measured using immunoassay. The outcome is the Spearman correlation coefficient.
Correlation between serum IL-6 concentration and serum Total Thyroxine (T4) levelsAt baseline, during routine hemodialysis visit (prior to any study-specific intervention)IL-6 (pg/mL) and total T4 (µg/dL) will be quantified using immunoassay. Outcome is the correlation coefficient (Spearman r).
Correlation between serum IL-6 concentration and Free Triiodothyronine (fT3) levelsAt baseline, during routine hemodialysis visit (prior to any study-specific intervention)IL-6 (pg/mL) and free T3 (pg/mL) measured using immunoassay analyzer. Outcome is Spearman correlation coefficient.
Correlation between serum IL-6 concentration and Free Thyroxine (fT4) levelsAt baseline, during routine hemodialysis visit (prior to any study-specific intervention)IL-6 (pg/mL) and fT4 (ng/dL) measured using immunoassay. Outcome is Spearman correlation coefficient (spearman r).

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026