Interleukin-6 and Thyroid Dysfunction in Hemodialysis Patients

NCT07328113 | Completed

• 1 other identifier: 175/KEP/2023
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease on Hemodialysis; Thyroid Gland Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation between serum Interleukin-6 (IL-6) concentration and serum Thyroid-Stimulating Hormone (TSH) levels

  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.

  At baseline, during routine hemodialysis visit (prior to any study-specific intervention)

Secondary Outcomes (4)

• Correlation between serum IL-6 concentration and serum Total Triiodothyronine (T3) levels

  At baseline, during routine hemodialysis visit (prior to any study-specific intervention)

• Correlation between serum IL-6 concentration and serum Total Thyroxine (T4) levels

  At baseline, during routine hemodialysis visit (prior to any study-specific intervention)

• Correlation between serum IL-6 concentration and Free Triiodothyronine (fT3) levels

  At baseline, during routine hemodialysis visit (prior to any study-specific intervention)

• Correlation between serum IL-6 concentration and Free Thyroxine (fT4) levels

  At baseline, during routine hemodialysis visit (prior to any study-specific intervention)

Interventions

Thyroid hormone DIAGNOSTIC_TEST

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.

Also known as: Interleukin-6

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population consists of all ESRD patients aged ≥ 21 years who undergo examinations at the Dialysis Unit of Universitas Airlangga Hospital, Surabaya. The accessible population includes all ESRD patients aged ≥ 21 years who undergo examinations at the Dialysis Unit of Universitas Airlangga Hospital, Surabaya, during the study period.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead
• Universitas Airlangga Hospital, Surabaya: collaborator

Study Sites (1)

Airlangga University Hospital

Surabaya, East Java, 60115, Indonesia

Location

MeSH Terms

Conditions

Thyroid Diseases; Renal Insufficiency, Chronic

Interventions

Thyroid Function Tests

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Endocrine; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sony Wibisono Mudjanarko, dr., Sp.PD, K-EMD, PhD

  Dr. Soetomo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 8, 2026
• Study Start: November 14, 2023
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: January 8, 2026

Record last verified: 2025-10

Locations

ID (1)