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

Completed

• Conditions: Chronic Renal Failure
• Interventions: Procedure: Blood Draw

• Registration Number: NCT00565994
• Lead Sponsor: University of Oklahoma

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.

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.

Study Timeline

• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Study First Posted: 2007-11-30
• Study Start: 2008-01
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-27
• Last Update Posted: 2010-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Blood Draw	Male and female healthy volunteers
Hemodialysis patients	Blood Draw	Male and female patients undergoing hemodialysis therapy as outpatients
Pre-dialysis patients	Blood Draw	Male and female patients with Stage 3, 4, or 5 chronic kidney disease, but not yet on dialysis

Trial Locations

Locations (1)

University of Oklahoma-Tulsa; 🇺🇸 Tulsa, Oklahoma, United States