Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00793806
First received: November 14, 2008
Last updated: June 12, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Device: Diffuse Optical Spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Medical Tool [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Diffuse Optical Spectroscopy measure blood values changes during the hemodialysis treatment.


Enrollment: 14
Study Start Date: August 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Device: Diffuse Optical Spectroscopy
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
Other Name: Diffuse Optical Spectroscopy measurements

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • acute kidney disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793806

Locations
United States, California
Beckman Laser Institute
Irvine, California, United States, 92612
UCIMC Dialysis center
Orange, California, United States, 92869
University of California Medical Center: Dialysis Unit
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Madeleine Pahl, M.D. University of California, Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, Madeleine Pahl, M.D., Associate Professor of Medicine and Director of the Renal Clinic, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00793806     History of Changes
Other Study ID Numbers: NIH-LAMMP-2007-5572
Study First Received: November 14, 2008
Last Updated: June 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on June 29, 2015