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NCT Number: NCT07328113

Interleukin-6 and Thyroid Dysfunction in Hemodialysis Patients

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Airlangga University Hospital

Surabaya, East Java, 60115, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Interleukin-6

Primary outcomes

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

    Time frame: At 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 outcomes

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

    Time frame: At 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.

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

    Time frame: At 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).

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

    Time frame: At 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.

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

    Time frame: At 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).

Sponsors and collaborators

Lead sponsor

Dr. Soetomo General Hospital

Other Gov

Collaborators

  • Universitas Airlangga Hospital, Surabaya

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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