Chronic Kidney DiseaseNCT00793806
Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by University of California, Irvine at 3 sites in United States.
Trial summary
The common causes of mortality are late stages of chronic kidney disease, cardiovascular disease and infections, are associated with abnormalities of the immune system, an underlying state of chronic inflammation and oxidative stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Diffuse Optical Spectroscopy
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2008to Mar 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 18 years and older with chronic kidney disease undergoing hemodialysis have been treated with hemodialysis for at least 3 months
- 18 years and older for control
Who cannot join
- acute kidney disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beckman Laser Institute
Irvine, California, 92612
University of California Medical Center: Dialysis Unit
Orange, California, 92868
UCIMC Dialysis center
Orange, California, 92869
About this study
The common causes of mortality are late stages of chronic kidney disease, cardiovascular disease and infections, are associated with abnormalities of the immune system, an underlying state of chronic inflammation and oxidative stress. These processes have not been carefully described in the chronic kidney disease population. The researcher can use Diffuse Optical Spectroscopy to determine the immune system in individuals with chronic kidney disease and describe the association with chronic inflammation and oxidative stress in that population.
Read the detailed description
The Diffuse Optical Spectroscopy can measure the absolute concentrations of reduced and oxygenated hemoglobins,cardiac output, mean arterial pressure, blood loss,blood hemoglobin concentration, water and lipid concentrations of the tissue.
The researchers can use Diffuse Optical Spectroscopy to monitor volume changes during the hemodialysis treatment and to correlate the changes in volume and blood pressure with the measures of oxidative stress and inflammation used in this study. The researchers can use Diffuse Optical Spectroscopy data to compare to laboratory parameters routinely measured to clinical parameters such as cause of chronic kidney disease, blood pressure and dialysis-related parameters.
- Conditions
- Chronic Kidney Disease
- Being tested
- Diffuse Optical Spectroscopy
- Keywords
- chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse Optical SpectroscopyDevice
Also called Diffuse Optical Spectroscopy measurements
Diffuse Optical Spectroscopy measurements will be compared to a variety of laboratory parameters routinely measured in Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease
| Study group | Role | What they receive |
|---|---|---|
| Medical Tool | Diffuse Optical Spectroscopy measurements will be compared to a variety of laboratory parameters routinely measured in Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease Receives: Device: Diffuse Optical Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Tool
Diffuse Optical Spectroscopy measure blood values changes during the hemodialysis treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Madeleine Pahl, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793806
- Sponsor's protocol ID
- 20075572
- Status last verified
- Oct 2022
- First submitted
- 14 Nov 2008
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00793806
- Acronym / sponsor ID
- 20075572
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Aug 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Nov 2008 (estimated)
- 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.
The common causes of mortality are late stages of chronic kidney disease, cardiovascular disease and infections, are associated with abnormalities of the immune system, an underlying state of chronic inflammation and oxidative stress. These processes have not been carefully described in the chronic kidney disease population. The researcher can use Diffuse Optical Spectroscopy to determine the immune system in individuals with chronic kidney disease and describe the association with chronic inflammation and oxidative stress in that population.
Detailed description
The Diffuse Optical Spectroscopy can measure the absolute concentrations of reduced and oxygenated hemoglobins,cardiac output, mean arterial pressure, blood loss,blood hemoglobin concentration, water and lipid concentrations of the tissue.
The researchers can use Diffuse Optical Spectroscopy to monitor volume changes during the hemodialysis treatment and to correlate the changes in volume and blood pressure with the measures of oxidative stress and inflammation used in this study. The researchers can use Diffuse Optical Spectroscopy data to compare to laboratory parameters routinely measured to clinical parameters such as cause of chronic kidney disease, blood pressure and dialysis-related parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Tool | – | Device: Diffuse Optical SpectroscopyDiffuse Optical Spectroscopy measurements will be compared to a variety of laboratory parameters routinely measured in Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- 18 years and older with chronic kidney disease undergoing hemodialysis have been treated with hemodialysis for at least 3 months
- 18 years and older for control
Key exclusion criteria (1 listed)
- acute kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffuse Optical SpectroscopyAlso: Diffuse Optical Spectroscopy measurementsDiffuse Optical Spectroscopy measurements will be compared to a variety of laboratory parameters routinely measured in Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease | Device | Medical Tool |
Primary outcome
Medical Tool
Time frame: 4 weeks
Diffuse Optical Spectroscopy measure blood values changes during the hemodialysis treatment.
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 20 Oct 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.
Madeleine Pahl, M.D. principal investigator
University of California, Irvine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University of California, Irvine at 3 sites in United States.
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 2 inclusion and 1 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 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Medical Tool (time frame: 4 weeks). 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 20 Oct 2022.