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

Recruiting

• Conditions: 1. Non-maturation of an arteriovenous fistula; <br />3. Computer simulation model.; <br />2. Flow prediction

• Registration Number: NL-OMON20401
• Lead Sponsor: 1. University of Technology Eindhoven, Department of Biomedical Engineering;<br>2. University Hospital Maastricht, Department of Surgery.

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

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;

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;

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br /><br>2. A model for postoperative flow prediction that is clinically evaluated for 60 patients;<br /><br>3. A model that is able to predict hypoperfusion;<br /><br>4. A model for hypoperfusion that is clinically evaluated for 60 patients.

Secondary Outcome Measures

Name	Time	Method
Pilot study:<br /><br>1. A measurement protocol to determine the vessel compliances by using ultrasound;<br /><br>2. A measurement protocol to determine the patient's geometry by using CE-MRA.