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
  Purpose

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.


Condition Intervention
Chronic Renal Failure
Procedure: Blood Draw

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Study of Cytokine and Inflammatory Markers in Patients With Chronic Renal Failure According to Their Method of Vascular Access

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 60
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hemodialysis patients
Male and female patients undergoing hemodialysis therapy as outpatients
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.
Control
Male and female healthy volunteers
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.
Pre-dialysis patients
Male and female patients with Stage 3, 4, or 5 chronic kidney disease, but not yet on dialysis
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565994

Locations
United States, Oklahoma
University of Oklahoma-Tulsa
Tulsa, Oklahoma, United States, 74135
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: William C Jennings, MD University of Oklahoma-Tulsa
  More Information

No publications provided

Responsible Party: William Jennings, MD, University of Oklahoma-Tulsa, Dept. of Surgery
ClinicalTrials.gov Identifier: NCT00565994     History of Changes
Other Study ID Numbers: OUHSC IRB #13137
Study First Received: November 29, 2007
Last Updated: September 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
hemodialysis
Vascular access
arteriovenous fistula
indwelling percutaneous catheters
arteriovenous grafts

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 15, 2014