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NCT01693263 · ClinicalTrials.gov registry record
Outcome of BCF Access in Hemodialysis Patients
A clinical trial of End Stage Renal Disease (ESRD) and Dialysis, sponsored by University of Chicago.
- Active
- Registry status
- 96
- Enrollment target
- 1
- Study location
NCT01693263: Active study of End Stage Renal Disease (ESRD) and Dialysis, sponsored by University of Chicago.
NCT01693263 is a study of End Stage Renal Disease (ESRD) and Dialysis that is active but no longer recruiting, run by University of Chicago. The registered enrollment target is 96 participants, below the 367-participant average among 10 other End Stage Renal Disease (ESRD) trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01693263, a study of End Stage Renal Disease (ESRD) and Dialysis, is active but no longer recruiting, sponsored by University of Chicago.
- ACTIVE NOT RECRUITING
- Registry status
- 96 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER brachiocephalic fistula (BCF)
Study Locations (1)
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2011-10 |
| Est. Completion | 2026-02 |
What the registry record for NCT01693263 still lists
NCT01693263 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 367-participant average among 10 other End Stage Renal Disease (ESRD) trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with End Stage Renal Disease (ESRD) appearing as the primary indexed condition, and to 1 intervention - of which brachiocephalic fistula (BCF) is the first listed.
NCT01693263 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01693263 about?
NCT01693263 is a clinical study titled "Outcome of BCF Access in Hemodialysis Patients". 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 ...
What is the current status of trial NCT01693263?
This trial is currently active not recruiting. The enrollment target is 96 participants. The study started on 2011-10. Estimated completion is 2026-02.
What conditions does trial NCT01693263 study?
This clinical trial studies the following conditions: End Stage Renal Disease (ESRD), Dialysis, Brachiocephalic Fistula (BCF), Cephalic Arch Stenosis (CAS).
What interventions are being tested in trial NCT01693263?
The interventions under investigation include: brachiocephalic fistula (BCF) (OTHER).
Who is sponsoring clinical trial NCT01693263?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01693263 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01693263's enrollment target sits among peer trials
96 6th of 10 higher than 5 of 10 other End Stage Renal Disease (ESRD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease (ESRD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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