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Postoperative flow prediction after creation of a vasculair access for hemodialysis with the aid of a computer simulation model.

Vascular remodeling after the creation of an arteriovenous fistula as angioaccess for hemodialysis: the predictive value of a patient-specific computer simulation model.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20401
Enrollment
60
Registered
2007-12-19
Start date
2008-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Non-maturation of an arteriovenous fistula

Interventions

All participants in this study will receive both pre- and postoperatively a CE-MRA examination, a duplex examination (only preoperatively) and pressure measurements (radial artery and finger). The dur

Sponsors

1. University of Technology Eindhoven, Department of Biomedical Engineering; 2. University Hospital Maastricht, Department of Surgery.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pre-dialysis patients with a detoriation of kidney function and an expected start with hemodialysis within three months and patients that are approved to receive a vascular access based on preoperative diagnostics; 2. Dialysis patients for which it becomes necessary to create a new vascular access because the old vascular access has become useless for proper hemodialysis. In addition, the patients should be approved to receive a vascular access in the contralateral arm based on preoperative diagnostics; 3. Only patients with an age of 18 years and older are included.

Exclusion criteria

Exclusion criteria: 1. Standard contra-indications for CE-MRA (ferromagnetic implants that can possibly move, pacemakers or claustrofobia). For patients with such implants, we use Shellock's most updated manual to determine if we can make the scan or not; 2. Possible or proved over-sensitivity for the Gadolinium containing contrast agent; 3. Patients younger than 18 years old.

Design outcomes

Primary

MeasureTime frame
1. A model that is able to predict the patient-specific postoperative flow with a maximum deviation of 10% compared to the measured postoperative flow; 2. A model for postoperative flow prediction that is clinically evaluated for 60 patients; 3. A model that is able to predict hypoperfusion; 4. A model for hypoperfusion that is clinically evaluated for 60 patients.

Secondary

MeasureTime frame
Pilot study: 1. A measurement protocol to determine the vessel compliances by using ultrasound; 2. A measurement protocol to determine the patient's geometry by using CE-MRA.

Contacts

Public ContactWouter Huberts
w.huberts@tue.nl+31 43 387 6291

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)