Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease (CKD)
| Tracking Information | |||||
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| First Received Date ICMJE | November 14, 2008 | ||||
| Last Updated Date | December 26, 2012 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
clinical parameters cause of chronic kidney disease [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00793806 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Immunologic Abnormalities, Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease (CKD) | ||||
| Official Title ICMJE | Non-invasive Spectroscopic Measurements of the Concentrations of Blood, Water, and Lipids in Tissues | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | primary care clinic |
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| Condition ICMJE | Chronic Kidney Disease | ||||
| Intervention ICMJE | Device: Diffuse Optical Spectroscopy
near-infrared (NIR)
Other Name: DOS |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 14 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00793806 | ||||
| Other Study ID Numbers ICMJE | LAMMP DOS | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Montana Compton, University of California, Irvine | ||||
| Study Sponsor ICMJE | Montana Compton | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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