Active — Not RecruitingNot Applicable

Outcome of BCF Access in Hemodialysis Patients

United States96 participantsStarted 2011-10

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pr…

What they're measuring

Hemodynamic profile in subjects with BCF

Timeframe: 5 years from start of study

Trial details

NCT IDNCT01693263

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02