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

Randomized-controlled clinical trial for the evaluation of the efficacy of computational simulation for the planning of vascular access surgery in hemodialysis patients - ShuntSimulationStudy (3S)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44805

Enrollment

236

Registered

2015-04-22

Start date

2015-06-02

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Non-maturation primary failure

Interventions

Randomization for the type of surgical vascular access creation (fore- or upper arm AVF).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Occurrence of non-maturation. Yes/no; proportion in both study groups.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)