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

NCT ID: NCT00565994

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Renal Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hemodialysis patients

Male and female patients undergoing hemodialysis therapy as outpatients

Blood Draw

Intervention Type 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

Male and female healthy volunteers

Blood Draw

Intervention Type 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.

Pre-dialysis patients

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

Blood Draw

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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University of Oklahoma-Tulsa, Dept. of Surgery

Principal Investigators

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William C Jennings, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma-Tulsa

Locations

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University of Oklahoma-Tulsa

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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OUHSC IRB #13137

Identifier Type: -

Identifier Source: org_study_id