Randomized-controlled clinical trial for the evaluation of the efficacy of computational simulation for the planning of vascular access surgery in hemodialysis patients

Completed

• Conditions: Non-maturation; primary failure; 10029149; 10003184

• Registration Number: NL-OMON44805
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 236

Inclusion Criteria

Incident patients that enter the pre-dialysis program because of end-stage renal failure
and need for vascular access.
Permanent dialysis patients in need of a new VA in the contralateral arm because of a previous failed access.

Exclusion Criteria

Patients with contraindications for creation of an autologous AVF (skin infection, ischemia, heart failure).
Previous vascular access in ipsilateral arm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Occurrence of non-maturation. Yes/no; proportion in both study groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Occurrence of high-flow complications (i.e., heart failure, distal ischemia).<br /><br>Yes/no, proportions in both study groups.<br /><br>Duration of primary patency.<br /><br>Influence of comorbidities and medication on the outcome of AVF creation.<br /><br>Degree of agreement between predicted and measured postoperative flow.<br /><br>AVF functionality and time-to.</p><br>