Elevated Levels of Antibodies to Endotoxin Core in Hemodialysis Patients With Peripheral Artery Disease

NCT05752968 | Completed DMC

• 1 other identifier: 111064
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Background Peripheral arterial disease (PAD) and its relevant complications are more common in hemodialysis (HD) patients. The potential association regarding chronic kidney disease dysbiosis, inflammation and metabolic endotoxinemia in HD patients is unknown. A cross-sectional study will be carried out the evaluate the possible association endotoxin core antibody with asymptomatic PAD in a cohort of HD patients. Methods This cohort study enrolled 500 HD patients treated at a single center in Taichung city. Fasting blood samples will be collected to determine biochemical data Endotoxin core antibody levels and other related biomarkers. By the automatic oscillometric method, the ankle-brachial index (ABI) was measured. Low ABI was defined as any value \< 0.9.

Conditions

Endotoxemia; Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Endotoxin core antibody

Outcome Measures

Primary Outcomes (1)

• Analysis of biomarkers of endotoxin core antibody (EndoCab) levels

  Plasma level of endotoxin core antibody (EndoCab) is a biomarkers for the risk of developing and presence of PAD

  1 years

Secondary Outcomes (5)

• Ankle Brachial Index Measurements

  1 years

• Analysis of biomarkers of IL-6

  1 years

• Analysis of biomarkers of sCD14

  1 years

• Analysis of biomarkers of LCN-2 (Lipocalin-2)

  1 years

• Analysis of biomarkers of YKL-40

  1 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients have to be at least 20-years-old and hemodialysis (HD) for at least 1 months.

You may qualify if:

• A cohort of aged 20 or over, who receive hemodialysis with ultrapure dialysate three times weekly for at least 1 month.

You may not qualify if:

• We will exclude patients dialyzed with a catheter; who had an acute infection requiring hospitalization; and who had underlying malignancy or autoimmune diseases. In addition, patients who refuse to participate will be excluded.

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Endotoxemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: May 3, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

TW (1)