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

NCT00565994 | Completed

• 1 other identifier: OUHSC IRB #13137
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure

Keywords

hemodialysis; Vascular access; arteriovenous fistula; indwelling percutaneous catheters; arteriovenous grafts

Study Arms (3)

Hemodialysis patients

Male and female patients undergoing hemodialysis therapy as outpatients

Procedure: Blood Draw

Control

Male and female healthy volunteers

Procedure: Blood Draw

Pre-dialysis patients

Male and female patients with Stage 3, 4, or 5 chronic kidney disease, but not yet on dialysis

Procedure: Blood Draw

Interventions

Blood Draw PROCEDURE

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; Hemodialysis patients; Pre-dialysis patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• to 90 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma-Tulsa

Tulsa, Oklahoma, 74135, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• William C Jennings, MD

  University of Oklahoma-Tulsa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 28, 2010

Record last verified: 2010-09

Locations

US (1)