Systemic Inflammatory Response SyndromeNCT03427307
Serum Level of Lipopolysaccharide-binding Protein (LBP) and Atherosclerosis in Hemodialysis Patients
An observational study of Systemic Inflammatory Response Syndrome, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammatory Response Syndrome
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jun 2018to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.
Who may be able to join
- Both sexes aged between 20-90 years.
- Received stable hemodialysis at least 3 months.
- Written informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Lipopolysaccharide-binding Protein (LBP) and Atherosclerotic Vascular Disease in Taiwanese Hemodialysis Patients
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.
Read the detailed 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.
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- Lipopolysaccharide-binding protein, inflammation, ASCVD
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Atherosclerotic events
Incident atherosclerotic vascular events in HD patients
Measured: 3 years
Secondary outcomes (2)
All-cause mortality
The association of LBP with all-cause mortality
Measured: 3 years
Association with inflammatory markers
TNF-alpha, Interleukin-10(IL-10), Interleukin-6 (IL-6) and soluble (sCD14) are measured using an enzyme-linked immunosorbent assay (ELISA) annually
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start3 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tungs' Taichung Metroharbour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paik Seong Lim, PhD, Principal investigator, Tungs' Taichung Metroharbour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427307
- Sponsor's protocol ID
- 106064
- Status last verified
- May 2022
- First submitted
- 27 Jan 2018
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Lipopolysaccharide-binding Protein (LBP) and Atherosclerotic Vascular Disease in Taiwanese Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03427307
- Acronym / sponsor ID
- 106064
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- Lipopolysaccharide-binding protein, inflammation, ASCVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Tungs' Taichung Metroharbour HospitalUniversity, hospital or other
- Study start
- 3 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.
Key inclusion criteria (3 listed)
- Both sexes aged between 20-90 years.
- Received stable hemodialysis at least 3 months.
- Written informed consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atherosclerotic events
Time frame: 3 years
Incident atherosclerotic vascular events in HD patients
2 secondary outcomes
All-cause mortality
Time frame: 3 years
Association with inflammatory markers
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paik Seong Lim, PhD principal investigator
Tungs' Taichung Metroharbour Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammatory Response Syndrome, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atherosclerotic events (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.