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

This study is enrolling participants by invitation only.

First Received: November 14, 2008 Last Updated: August 31, 2009 History of Changes

Sponsor:	University of California, Irvine
Collaborators:	Beckman Laser Institute University of California Irvine Renal Clinic, University of California, Irvine Volighten Scientific, Ltd.
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00793806

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:	Case-Only, Prospective
Official Title:	Non-invasive Spectroscopic Measurements of the Concentrations of Blood, Water, and Lipids in Tissues

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
chronic kidney disease chronic kidney disease	Device: Diffuse Optical Spectroscopy near-infrared (NIR)

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

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

Locations

United States, California
University of California Medical Center: Dialysis Unit
Orange, California, United States, 92868
UCIMC Dialysis center
Orange, California, United States, 92869
Beckman Laser Institute
Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Beckman Laser Institute University of California Irvine

Renal Clinic, University of California, Irvine

Volighten Scientific, Ltd.

Investigators

Principal Investigator:

Madeleine Pahl, M.D.

Renal Clinic, University of California, Irvine

More Information

No publications provided

Responsible Party:	Renal Clinic, University of California, Irvine ( Madeleine V. Pahl, M.DAssociate Professor of Medicine and Director of the Renal Clinic at UCI. )
Study ID Numbers:	LAMMP DOS
Study First Received:	November 14, 2008
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00793806 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

chronic kidney disease

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on November 20, 2009