Serum Level of Lipopolysaccharide-binding Protein (LBP) and Atherosclerosis in Hemodialysis Patients

NCT03427307 | Completed DMC

• 1 other identifier: 106064
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Background In hemodialysis (HD) patients, impaired gut barrier and alteration in microbiota in the gut is thought to increase the risk of bacterial translocation and chronic inflammation. Lipopolysaccharide-binding protein (LBP) is an acute-phase reactant that mediates immune responses triggered by microbial products. Our aim is to investigate the relationship between circulating levels of LBP, inflammatory markers and incident atherosclerotic vascular events in HD patients and follow-up this defined cohort for 3 years. Methods A total of 300 HD patients will be recruited. The LBP and inflammatory markers will be determined using immuoassay methods annually. A bioimpedance spectroscopy device will used for body fat composition measurement and measurements will be done annually. Arterial stiffness is evaluated by measuring PWV in the heart-femoral segment using an automatic waveform analyzer.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

Lipopolysaccharide-binding protein; inflammation; ASCVD

Outcome Measures

Primary Outcomes (1)

• Atherosclerotic events

  Incident atherosclerotic vascular events in HD patients

  3 years

Secondary Outcomes (2)

• All-cause mortality

  3 years

• Association with inflammatory markers

  3 years

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.

You may qualify if:

• Both sexes aged between 20-90 years.
• Received stable hemodialysis at least 3 months.
• Written informed consent.

You may not qualify if:

• patients with severe infections, severe heart disease and liver disease, malignancy, autoimmune disorders, severe malnutrition, or clinical conditions requiring oral nutrition supplements;
• Inability to follow protocol.
• Pregnancy or wishing/trying to get pregnant

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: February 9, 2018
• Study Start: June 3, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

TW (1)