(1) To develop patient-specific hemodynamic models of arteriovenous grafts at multiple time points after surgery, thereby including venous outflow stenosis; (2) to determine the critical stenosis severity at which the arteriovenous graft is at risk…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Vascular therapeutic procedures
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will provide a descriptive evaluation of blood flow patterns and derived
parameters in our hemodynamic models, which is common practice in studies on
computational fluid dynamics simulations in vascular access. The secondary
study parameters are the degree of stenosis at which the graft is at risk of
thrombosis according to the computational fluid dynamics model, and the
associations between hemodynamic parameters and future stenosis development.
Secondary outcome
Not applicable.
Background summary
The most common complication of arteriovenous grafts for hemodialysis treatment
is stenosis at the venous outflow. Based on the idea that stenosis will lead to
thrombosis, it is common practice to correct hemodynamically significant
stenoses. However, randomized controlled trials have shown that these
preemptive interventions do not prevent graft thrombosis or access failure.
Personalised computational fluid dynamics modeling of arteriovenous grafts
gives insight into the local hemodynamics of arteriovenous grafts. These
computer simulations may eventually be helpful to predict the site of stenosis
and the risk of thrombosis in the vascular access.
Study objective
(1) To develop patient-specific hemodynamic models of arteriovenous grafts at
multiple time points after surgery, thereby including venous outflow stenosis;
(2) to determine the critical stenosis severity at which the arteriovenous
graft is at risk of thrombosis; and (3) to study associations between
hemodynamic parameters and future stenosis development.
Study design
Observational cohort study with a follow-up period of 1 year.
Study burden and risks
Patients will receive 2 MRI scans and 10 duplex ultrasound examinations within
the 1-year follow-up period. We will schedule the diagnostic studies before or
after dialysis sessions to reduce patient discomfort. Usual clinical practice
would be to have 5 duplex ultrasound examinations in this time period. There
are no risks or benefits associated with participating in the study.
P. Debyeplein 25
Maastricht 6202AZ
NL
P. Debyeplein 25
Maastricht 6202AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients receiving vascular access surgery at Maastricht UMC+
- Patients receiving a first ipsilateral upper arm arteriovenous graft
(straight and loop configurations and different graft materials can be included)
- Patients 18 years and older and mentally competent
Exclusion criteria
- Patients with a life expectancy of less than one year
- Patients with central venous stenosis at baseline
- Patients with contraindications for magnetic resonance imaging (MRI)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67174.068.19 |