A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure
| Tracking Information | |||||
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| First Received Date ICMJE | November 29, 2007 | ||||
| Last Updated Date | September 27, 2010 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00565994 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 | A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure | ||||
| Official Title ICMJE | A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure According to Their Method of Vascular Access | ||||
| Brief Summary | We hope to study components within the blood that may predict success, failure or other associated complications in relation to the type of vascular access being used. |
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| Detailed Description | Renal failure affects more than 350,000 patients in the United States. All patients undergoing dialysis must have access to the vascular system (blood stream) for hemodialysis treatment. Methods of access include a catheter, or tube, that goes through the skin and into a large vein, a surgically created connection of a vein to an artery called an AV fistula, or a surgically created connection of a vein to artery using a graft or plastic tube. Previous research has shown considerable differences in the function and success in these types of vascular access for dialysis. Research investigators try to explain these differences and find the causes and explanations for the variations seen in vascular access. Forty patients undergoing dialysis treatment will be evaluated by analyzing serum specimens obtained during outpatient hemodialysis access. Serum will also be collected from ten pre-dialysis patients and ten normal volunteers for comparison. Pre-dialysis patients are those who have Stage 3, 4, or 5 chronic kidney disease but are not yet on dialysis and have never had any type of created vascular access. Normal subjects will have no kidney disease, autoimmune disorders, recent (<6 months) chemotherapy treatment or corticosteroid use, or other chronic condition determined by the investigator to interfere with cytokine and inflammatory markers. The serum specimens will be analyzed for cytokine/inflammatory markers and correlated with clinical access type and other medical data and demographic information. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: serum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Male and female patients of Dr. William Jennings and Dr. Pranay Kathuria undergoing dialysis therapy as outpatients. Dialysis and pre-dialysis patients will be recruited from Dr. Pranay Kathuria's practice. Normal volunteers will be recruited from family members of the pre-dialysis patients, Internal Medicine patients already scheduled to have blood drawn for other reasons, or from faculty/staff/student volunteers who are not otherwise involved with the study and are not in a subordinate role to any of the study investigators. |
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| Condition ICMJE | Chronic Renal Failure | ||||
| Intervention ICMJE | Procedure: Blood Draw
For patients undergoing routine hemodialysis for chronic renal failure, 5-10 ml of blood will be removed from the dialysis tubing during vascular access. All other subjects will have 5-10 ml of blood drawn by routine venipuncture. |
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| Study Group/Cohort (s) |
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| 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 | 60 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| 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 | NCT00565994 | ||||
| Other Study ID Numbers ICMJE | OUHSC IRB #13137 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | William Jennings, MD, University of Oklahoma-Tulsa, Dept. of Surgery | ||||
| Study Sponsor ICMJE | University of Oklahoma | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Oklahoma | ||||
| Verification Date | September 2010 | ||||
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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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