Clinical trial NCT05096416: Three-dimensional (3D) Printed Hemodialysis Vascular Model
Official title: Three-dimensional (3D) Printed Hemodialysis Vascular Model for Increased Precision of Cannulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis Access Failure
Keywords: hemodialysis
Magnetic resonance angiography
three-dimensional (3D) printed hemodialysis vascular model
Vascular access complication
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Infiltration of a surgically-placed hemodialysis vascular access (HVA) is recognized as a major contributor to the high hospital re-admission rate in dialysis-dependent patients. Three dimensional modeling has been demonstrated as a critical tool for procedurists in preparation for surgical interventions but no such modeling is yet available for dialysis specialists to avoid the common complication of HVA infiltration. Contrast enhanced magnetic resonance angiography (MRA) can be used to generate a three dimensional image data that could render a three dimensional resin-based model of a vascular access.

Detailed description: Hemodialysis is the most common treatment for End Stage Renal Disease (ESRD). For an optimal renal replacement therapy, a patent vascular access (VA) is essential. The importance of good vascular access maintenance has been strongly supported by the guidelines (1). Various hinderances render this goal unachievable. A well-known cause of VA failure is access infiltration, which is usually overlooked in clinical practices (2). The calculated economic burden attributable to VA complication is between $16,864 -US$20,961 and more than 50% is due to access infiltration alone (3). Imaging has a pivotal pre- and post-operative role in evaluating vascular access complications. Imaging modalities such as ultrasound (US), Digital Subtraction Angiography (DSA) and Magnetic Resonance Angiography (MRA) are available but their use is limited due to the limited view of plane available for visualization of vessel anatomy(4) and because of the deleterious side effects of the contrast agents used (5,6). Contrast enhanced Magnetic Resonance Angiography (MRA) provides an excellent means of imaging the vasculature (7) which can be reconstructed in a three- dimensional(3D) print. The skill set of dialysis technician nurses play a considerable role in achieving successful cannulation of the fistula. Due oftentimes to complicated vascular anatomy, cannulation based on cutaneous anatomic landmarks and physical examination can be deceiving. Even a minor error in cannulation can impair access longevity(3). The 3D image reconstruction provides a practical solution to generate a 3D VA model which can be used by the procedurists to cannulate the patients, reducing the complications and rate of re admissions. Overall, a significant reduction in the health care cost can be achieved

Eligibility criteria: Inclusion Criteria:

* Patients with a surgically placed hemodialysis access which has been used in the last 90 days or is being prepared for use in the next 90 days

Exclusion Criteria:

* Patients with only failed hemodialysis surgical access(es) that has/have not been used for \>90 days.

Primary outcomes:
measure: Quantify the number of dialysis treatments completed
timeFrame: 12 month
Secondary outcomes:
measure: Quantify the number of vascular access interventions over a 12-month period compared to controls
timeFrame: 12 month
measure: Quantify annual hospitalization rate compared to controls
timeFrame: 12 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Andrew Siedlecki, MD
role: PRINCIPAL_INVESTIGATOR
References: