Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease (CKD)

This study has been completed.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Volighten Scientific, Ltd.
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00793806
First received: November 14, 2008
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

The Diffuse Optical Spectroscopy (DOS) measure the absolute concentrations of reduced and oxygenated hemoglobins ([Hb-R] and [HbO2], respectively) as well as the water and lipid concentrations of the tissue.


Condition Intervention
Chronic Kidney Disease
Device: Diffuse Optical Spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-invasive Spectroscopic Measurements of the Concentrations of Blood, Water, and Lipids in Tissues

Resource links provided by NLM:


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

Primary Outcome Measures:
  • clinical parameters cause of chronic kidney disease [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Device: Diffuse Optical Spectroscopy
    near-infrared (NIR)
    Other Name: DOS
Detailed Description:

DOS have been shown to correlate with invasive measures of cardiac output, mean arterial pressure, blood loss, and blood hemoglobin concentration.

The researchers want to use DOS as a means 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 want compared to a variety of laboratory parameters routinely measured in CKD subjects (GFR, proteinuria, Hg, serum albumin, bicarbonate, calcium, phosphorous, iron saturation, ferritin, lipid profiles, PTH) and to clinical parameters such as cause of CKD, 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
Montana Compton
Beckman Laser Institute University of California Irvine
Volighten Scientific, Ltd.
Investigators
Principal Investigator: Madeleine Pahl, M.D. University of California, Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00793806     History of Changes
Other Study ID Numbers: LAMMP DOS
Study First Received: November 14, 2008
Last Updated: December 26, 2012
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 October 23, 2014