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A Study Evaluating the Association of Inflammation With Hemodialysis Access Type

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ClinicalTrials.gov Identifier: NCT01011985
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : December 3, 2009
Sponsor:
Information provided by:
Montefiore Medical Center

Brief Summary:
To determine if the type of hemodialysis vascular access correlates with markers of inflammation, namely C-reactive protein and interleukin-6, and with both access and patient survival in the end stage renal disease population.

Condition or disease
End Stage Renal Disease Inflammation

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of the Effect of Hemodialysis Access Type on Markers of Inflammation
Study Start Date : August 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
AVF
Initial access is an AVF
AVG
Initial vascular access is an AVG
TC
Initial vascular access is a tunneled catheter, with or without a maturing AVF or AVG



Biospecimen Retention:   Samples Without DNA
serum


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Incident stage 4 and 5 chronic kidney disease patients receiving their first dialysis access.
Criteria

Inclusion Criteria:

  • CKD patients referred for their initial vascular access
  • Able to consent for surgery/study

Exclusion Criteria:

  • Active inflammatory states
  • Active infection
  • Autoimmune diseases
  • Acute renal allograft rejection
  • HIV positive status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011985


Locations
United States, New York
Montefiore Medical Center and Jack D Weiler Hospital
Bronx, New York, United States, 10457
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Michele H Mokrzycki, MD, MS Montefiore Medical Center

Responsible Party: Michele Mokrzycki, M.D., Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01011985     History of Changes
Other Study ID Numbers: 06-07-336E
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: December 2009

Keywords provided by Montefiore Medical Center:
end stage renal disease
inflammation
vascular access
hemodialysis

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