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A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00565994
First received: November 29, 2007
Last updated: September 27, 2010
Last verified: September 2010

November 29, 2007
September 27, 2010
January 2008
September 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00565994 on ClinicalTrials.gov Archive Site
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Not Provided
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A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure
A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure According to Their Method of Vascular Access

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

serum

Non-Probability Sample

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.

Chronic Renal Failure
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.
  • Hemodialysis patients
    Male and female patients undergoing hemodialysis therapy as outpatients
    Intervention: Procedure: Blood Draw
  • Control
    Male and female healthy volunteers
    Intervention: Procedure: Blood Draw
  • Pre-dialysis patients
    Male and female patients with Stage 3, 4, or 5 chronic kidney disease, but not yet on dialysis
    Intervention: Procedure: Blood Draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients of Dr. William Jennings and Dr. Pranay Kathuria undergoing dialysis therapy as outpatients
  • Male and female patients of Dr. Pranay Kathuria who have been diagnosed with Stage 3, 4, or 5 chronic kidney disease, but who are not yet on dialysis.
  • Healthy volunteers with 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.
  • 18 to 90 years of age

Exclusion Criteria:

  • under 18 years of age
  • over 90 years of age
  • prisoners
  • institutionalized patients
  • pregnant individuals
  • patients with mental illness who are not able to give informed consent
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00565994
OUHSC IRB #13137
No
William Jennings, MD, University of Oklahoma-Tulsa, Dept. of Surgery
University of Oklahoma
Not Provided
Principal Investigator: William C Jennings, MD University of Oklahoma-Tulsa
University of Oklahoma
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP