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A Study Evaluating the Association of Inflammation With Hemodialysis Access Type

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01011985
First received: November 9, 2009
Last updated: December 2, 2009
Last verified: December 2009
History of Changes
  Purpose

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
End Stage Renal Disease
Inflammation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of the Effect of Hemodialysis Access Type on Markers of Inflammation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 64
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Michele Mokrzycki, M.D., Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01011985     History of Changes
Other Study ID Numbers: 06-07-336E
Study First Received: November 9, 2009
Last Updated: December 2, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013