Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03427307 |
| Other study ID # |
106064 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 3, 2018 |
| Est. completion date |
January 31, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
Tungs' Taichung Metroharbour Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Study Design and Population
Patient Population
To be included in the study, patients have to be at least 20-years-old and on outpatient
hemodialysis (HD) for at least 3 months. Patients are excluded if they had an acute infection
or malignancy. A total of 360 long-term HD patients are randomly invited and agreed to
participate in the study. The medical record is thoroughly reviewed for each subject by a
collaborating physician in the study. Information such as underlying kidney disease,
cardiovascular disease history, and other comorbid illnesses will be abstracted.
Study Parameters
Predialysis blood samples are obtained on a mid-week day. Within 30 min after sampling, the
remaining blood is centrifuged at 3,000 g for 10 min, immediately aliquoted and frozen at
-70°C until further analysis. 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). Plasma levels of Interleukin-6 (IL-6) and
soluble CD14(sCD14) are measured by a commercially available enzyme linked immunosorbent
assay (ELISA) (Quantikine HS Immunoassay kit, R&D System, Minneapolis, MN). Concentrations
Interleukin-6(IL-10), and Tumor necrosis factor-alpha(TNF-α) are simultaneously determined by
the Multiplex® (R&D Systems, Minnesota, MN, USA). Serum levels of LBP will be measured using
a commercial enzyme-linked immunosorbent assay (HK315-02, HyCult Biotech Inc., Uden, the
Netherlands) as per manufacturer's instructions. The intra- and inter-assay coefficients of
LBP variation are <5 and <10%, respectively. Besides, serum from 40 normal control subjects
will be used for interassay variation. Both the intra- and the interassay coefficients of
variation were <8.0%. All samples will be measured in duplicates and the mean value is
reported in μg/mL
Percent fat is measured with Bioelectric Impedance Spectroscopy
Whole-body bioelectric impedance spectroscopy (BIS) measurement using a body composition
monitor (BCM: Fresenius Medical Care, Bad Homburg, Germany) is performed on each of the
participants enrolled in the study as described previously [28]. Briefly, measurements were
taken on the day before dialysis with the patient calm, supine, and relaxed in the dialysis
bed for 10 minutes. Four electrodes were placed on the patient's hand and foot on the side
contra lateral to their arteriovenous fistula. The basic principle of this machine is the use
of the bioimpedance spectroscopy which determines the fluid content of the body by measuring
the serial values of electric impedance by applying small microAmp electric currents at 50
different frequencies between 5 and 1000 kHz. These impedance data are used to obtain the
amount of total body water, intracellular water and extracellular water through a special
fluid model and information about other body compositions, such as fat tissue or lean tissue,
through a physiological body composition model [29]. The major estimates the body composition
measured by BCM-BIS are as follows: (1) lean tissue mass (LTM -mainly muscle), fat mass
(FAT), and adipose tissue mass (ATM-mainly fat with its relevant hydration)
Measurement of arterial stiffness
Arterial stiffness is evaluated by measuring PWV in the heart-femoral segment using an
automatic waveform analyzer.
