Outcome of BCF Access in Hemodialysis Patients

NCT01693263 | Active Not Recruiting

• 2 other identifiers: 11-02695R01DK090769-02
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease (ESRD); Brachiocephalic Fistula (BCF); Cephalic Arch Stenosis (CAS); Dialysis

Keywords

end stage renal disease (ESRD); brachiocephalic fistula (BCF); cephalic arch stenosis (CAS); dialysis

Outcome Measures

Primary Outcomes (1)

• Hemodynamic profile in subjects with BCF

  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.

  5 years from start of study

Secondary Outcomes (1)

• Geometric change in cephalic arch in subjects with BCF

  5 years from the start of the study

Study Arms (2)

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)

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 50 subjects. For the purposes of this sub-study the following will take place: Intravenous Ultrasound (IVUS) and Hand Held Doppler

Interventions

brachiocephalic fistula (BCF) OTHER

We will collect information from physical exams, blood tests, venogram, doppler, vein and artery tissue samples

brachiocephalic fistula placed

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• No history of hemodialysis prior to BCF access placement
• History of hemodialysis prior to BCF access placement

Sponsors & Collaborators

• University of Chicago: lead
• National Institutes of Health (NIH): collaborator
• Illinois Institute of Technology: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

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.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Hammes, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: September 26, 2012
• Study Start: October 1, 2011
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

US (1)