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Outcome of BCF Access in Hemodialysis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Chicago
Sponsor:
Collaborators:
Weiss Memorial Hospital
Illinois Institute of Technology
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01693263
First received: August 8, 2012
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

Dialysis access, which is the connection that allows blood to flow in and out of the body during dialysis sessions, is important to remove wastes and excess fluid for patients with end stage renal disease (ESRD). One method used to access the vein and artery for dialysis is called a brachiocephalic fistula. Patients are being asked to participate in this study because they have endstage renal disease, and their doctor has recommended that they will have brachiocephalic fistula placed for their dialysis access.

A common problem seen in patients with a brachiocephalic fistula (BCF) is cephalic arch stenosis (CAS). CAS is a narrowing in the central vein (located in the upper chest). CAS causes problems with the opening of the veins and arteries needed for dialysis. Once someone suffers CAS they may need several radiology procedures as well as surgery to help correct the problem.

The BCF may fail once CAS develops.

The purpose of the research study is to gather information about the BCF and what is happening inside the vein. The researchers hope to find out what may be the cause of CAS.


Condition Intervention
End Stage Renal Disease (ESRD)
Brachiocephalic Fistula (BCF)
Cephalic Arch Stenosis (CAS)
Dialysis
Other: brachiocephalic fistula (BCF)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical and Computational Study to Improve Brachiocephalic Fistula (BCF) Outcomes

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Hemodynamic profile in subjects with BCF [ Time Frame: 5 years from start of study ] [ Designated as safety issue: Yes ]
    Observe a cohort of BCF subjects over time with protocol venograms and Dopplers and calculate WSS, along with other HDP, using CFD. This will enable a life table analysis to be derived to estimate the effect of WSS on time to CAS.


Secondary Outcome Measures:
  • Geometric change in cephalic arch in subjects with BCF [ Time Frame: 5 years from the start of the study ] [ Designated as safety issue: Yes ]
    Correlation of maximum change in average venous radius and change in arch angle with type of fistula, initial arch angle, and inlet pressure at the time of fistula formation.


Biospecimen Retention:   Samples With DNA

Whole Blood Viscosity (WBV), Hematocrit, and ADMA: WBV will be measured by Brookfield Programmable DV-II+ cone plate viscometer. ADMA will be measured by ADMA ELISA kit. The samples will be collected every 6 months on all subjects and frozen to be run in aliquots of 50.

Cephalic Vein and Arterial Tissue Samples: During placement of BCF vein and arterial tissue are excised during anastomosis to create the fistula. After the tissue is removed from the vein and artery a small portion of each will be removed and collected for research from this discarded material. The cephalic vein and arterial samples will be collected and preserved in a tissue bank for later review by light and electron microscopy in a subsequent study.


Estimated Enrollment: 110
Study Start Date: October 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
brachiocephalic fistula placed
Subjects are being asked to participate in this study because they have end-stage renal disease and they are undergoing dialysis, and their doctor has recommended that they will have brachiocephalic fistula placed for their dialysis access.
Other: brachiocephalic fistula (BCF)
We will collect information from physical exams, blood tests, venogram, doppler, vein and artery tissue samples
Sub-study participants
As part of this study there is an additional sub-study. The researchers would like to collect more information about the vascular access from 10 subjects. For the purposes of this sub-study the following will take place: Intravenous Ultrasound (IVUS) and Hand Held Doppler

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects for consideration in the study will be those referred from the out-patient nephrology clinic at the University of Chicago or a dialysis unit affiliated with DaVita Dialysis for a primary AVF. Eligible patients are those who are evaluated at the University of Chicago or Weiss Hospital by a transplant or vascular surgeon. If the treating surgeon determines that the patient will have an attempted BCF, these patients will be eligible to participate in this study. The research team will be notified of a potential subject.

Criteria

Inclusion Criteria:

  • Subjects enrolled in the study will include patients with irreversible chronic renal failure; either those receiving chronic hemodialysis or anticipation that hemodialysis will be required.
  • Subjects for consideration in the study will be referred from the out-patient nephrology clinic at the University of Chicago or a dialysis unit affiliated with DaVita Dialysis for a primary AVF. The patient will be referred for AVF placement and evaluated at the University of Chicago by a transplant or vascular surgeon. If it is determined that the patient is a candidate for fistula placement, the surgeon will decide based on physical exam, the best location for the access. If the optimal location is a proposed BCF, a research coordinator will be notified and the patient will be enrolled by written consent approved by the IRB from the University of Chicago.
  • Subjects who can provide consent or consent of a surrogate through proxy

Exclusion Criteria:

  • Patients will be excluded if they are less than 21 years of age
  • Pregnant females will be excluded. A careful history will be taken and women who are pregnant or have a clinical indication will have a serum pregnancy test with a positive result will be excluded.
  • Those with a known history of anaphylaxis from contrast
  • Those who are found to be ineligible to have a surgical placement of a BCF as determined by the surgeon

Additional Criteria for the sub-study

Inclusion Criteria:

  • No history of hemodialysis prior to BCF access placement

Exclusion Criteria:

  • History of hemodialysis prior to BCF access placement
  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: NCT01693263

Contacts
Contact: Mary Hammes, MD (773) 702-9892 mhammes@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Mary Hammes, MD    773-702-9892    mhammes@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Weiss Memorial Hospital
Illinois Institute of Technology
Investigators
Principal Investigator: Mary Hammes, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01693263     History of Changes
Other Study ID Numbers: 11-0269, 5R01DK090769-02
Study First Received: August 8, 2012
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
end stage renal disease (ESRD)
brachiocephalic fistula (BCF)
cephalic arch stenosis (CAS)
dialysis

Additional relevant MeSH terms:
Fistula
Kidney Diseases
Kidney Failure, Chronic
Pathological Conditions, Anatomical
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014