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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05752968
Other study ID # 111064
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2023
Est. completion date December 31, 2023

Study information

Verified date February 2024
Source Tungs' Taichung Metroharbour Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Study Design and Patients This is a cross-sectional study involving hemodialysis patients from the hemodialysis unit of Tungs' Taichung MetroHarbor Hospital, Taiwan. A total of 500 patients over 20 years of age who receive hemodialysis with ultrapure dialysate three times weekly for at least 1 month are eligible for enrollment. 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. Information on participant demographics and comorbidities will be obtained from interviews and medical record reviews at the time of enrollment. Diabetes mellitus is defined by self-reported history or use of antidiabetic medications. Hypertension was defined as systolic blood pressure ≥140 mmHg, diastolic ≥90 mmHg, or use of antihypertensive agents. Pre-exisiting CVD is defined as coronary artery disease, as documented by coronary angiography or a history of myocardial infarction, class III or IV congestive heart failure, or stroke. This study will comply with the Declaration of Helsinki and will apply for approval from the Institutional Review Board of Tungs' Taichung MetroHarbor Hospital. All participants will give their written informed consent. Laboratory Measurements Predialysis blood samples are obtained on a mid-week day. Within 30 min after sampling, the remaining blood will be centrifuged at 3,000 g for 10 min, immediately aliquoted and frozen at-70 °C until further analysis. The total serum cholesterol is measured through the reaction of cholesterol esterase/cholesterol oxidase/ peroxidase, using Hitachi 747 (Hitachi, Bohemia, NY, USA). HDL cholesterol is quantified after precipitation with polyethylene glycol at room temperature. Serum glucose concentrations are measured by the glucose oxidase method. Low-density lipoprotein cholesterol is calculated using the Friedewald formula. Total serum triglycerides are measured through the reaction of glycerol/ phosphate/oxidase and peroxidase. The serum levels of high-sensitivity C-reactive protein (hsCRP) are measured using a Behring Nephelometer II (Dade Behring, Tokyo, Japan). Serum levels of IL-6 and sCD14 are measured by a commercially available enzyme-linked immunosorbent assay (Quantikine HS Immunoassay kit, R&D System, Minneapolis, MN, USA). The LBP will be determined from serum samples and controls using standardized enzyme-linked immunosorbent assay methods (HK315-02, HyCult Biotech Inc., Uden, The Netherlands), and serum from 20 normal control subjects are used for interassay variation. Serum endotoxin core antibody will be tested using a commercially available EndoCab IgG ELISA assay (Hycult Biotech Inc., The Netherlands). In addition, serum LCN-2 (Lipocalin-2) and YKL-40 concentrations will be determined using enzyme linked immunosorbent assays Endotoxin Measurement Endotoxin levels are measured using a Charles River Laboratories (CRL) Kinetic Chromogenic assay, Endochrome-K. A more detailed description of the methodology used has been described elsewhere [37]. Samples are thawed and diluted to 1 : 20 with a bio-dispersing agent (CRL, BD100) and heat to 75°C for 15 minutes. A standard curve (0.005 EU/mL and 5 EU/mL) is prepared using control standard endotoxin supplied by CRL. If endotoxin is detected, the samples are then reconstituted with an endotoxin-specific buffer (Charles River Endosafe BG-120) to avoid any β-glucan-related false positive reaction. A positive product control is included for each sample to eliminate the possibility of enhancement or inhibition of endotoxin measurement. The absorbance at 405 nm is measured at 30 second intervals for a total of 3600 seconds using a Biotek ELx808 plate reader. The assay reactions are held at 37°C throughout the assay period. Charles River Endosafe, EndoScan V software is used to generate a standard curve and analyze data using an onset time of 0.1 absorbance unit.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - A cohort of aged 20 or over, who receive hemodialysis with ultrapure dialysate three times weekly for at least 1 month. Exclusion Criteria: - 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.

Study Design


Locations

Country Name City State
Taiwan Tungs' Taichung MetroHarbour Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
Tungs' Taichung Metroharbour Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ankle Brachial Index Measurements Diagnostic criterion for asymptomatic PAD 1 years
Secondary Analysis of biomarkers of IL-6 The IL-6 was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods 1 years
Secondary Analysis of biomarkers of sCD14 The sCD14 was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods assay (ELISA) methods 1 years
Secondary Analysis of biomarkers of LCN-2 (Lipocalin-2) The LCN-2 (Lipocalin-2) was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods 1 years
Secondary Analysis of biomarkers of YKL-40 The YKL-40 was determined from plasma samples using standardized enzymelinked immunosorbent assay (ELISA) methods 1 years
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