Interleukin-6 and Thyroid Dysfunction in Hemodialysis Patients

NCT ID: NCT07328113

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2024-06-30

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.

Conditions

Chronic Kidney Disease on Hemodialysis; Thyroid Gland Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Thyroid 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Interleukin-6

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Airlangga Hospital, Surabaya

UNKNOWN

Sponsor Role: collaborator

Dr. Soetomo General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Dr. Soetomo General Hospital

Locations

Airlangga University Hospital

Surabaya, East Java, Indonesia

Countries

Indonesia

Other Identifiers

175/KEP/2023

Identifier Type: -

Identifier Source: org_study_id