Three-dimensional (3D) Printed Hemodialysis Vascular Model

Hemodialysis Access Failure Clinical Trial

Official title:

Three-dimensional (3D) Printed Hemodialysis Vascular Model for Increased Precision of Cannulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05096416
• Other study ID #: 2022P000658
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2022
• Source: Brigham and Women's Hospital
• Contact: Andrew Siedlecki, MD
• Phone: +13148092879
• Email: asiedlecki[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis Access Failure

Intervention

Device:
• The three-dimensional (3D) printed hemodialysis vascular model
The three-dimensional (3D) printed hemodialysis vascular model will be used as a guide map to cannulate the patients for hemodialysis and to minimize the risk of vascular access complications

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify the number of dialysis treatments completed		12 month
Secondary	Quantify the number of vascular access interventions over a 12-month period compared to controls		12 month
Secondary	Quantify annual hospitalization rate compared to controls		12 month