We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Evaluating the Association of Inflammation With Hemodialysis Access Type

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01011985
First Posted: November 11, 2009
Last Update Posted: December 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Montefiore Medical Center
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Michele Mokrzycki, M.D., Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01011985     History of Changes
Other Study ID Numbers: 06-07-336E
First Submitted: November 9, 2009
First Posted: November 11, 2009
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