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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014