NCT02453412

Brief Summary

Patients suffering from end-stage renal disease (ESRD) are dependent on renal replacement therapy (dialysis). The majority of dialysis is facilitated by hemodialysis. For hemodialysis a vascular access is necessary, preferable an arteriovenous fistula (AVF) in which a vein is directly anastomosed to an artery. In order to use the AVF for hemodialysis three criteria have to be met; the minimal flow over the AVF is 600 mL/min, the diameter is at least 6 mm, and the AVF is located less than 6 mm under the skin. Unfortunately, approximately half of the patients (50%) are confronted with an AVF that does not meet these criteria; the so called non-maturation or primary failure. In case of non-maturation the AVF is not only unusable for dialysis, but also requires reinterventions on short- and long-term. Firstly to mature the AVF, and secondly, when the AVF is matured, to keep the vascular access. Using a computational simulation postoperative flow can be predicted. Based on patient-specific duplex measurements, the model can calculate the flow that can be expected following vascular access surgery for all AVF configurations; fore- or upper arm. These calculations lead to an advice which configuration is indicated; a flow that exceeds 600 mL/min, leading to maturation. Potentially the aforementioned 50% of non-maturation can be reduced. The patient then has an adequate vascular access and reinterventions are adverted, resulting in a decrease of costs, hospital demand, and an increase of the patients' quality of life. When the expected reduction of non-maturation is confirmed, the computational tool can be offered to other hospitals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

May 12, 2015

Last Update Submit

August 20, 2019

Conditions

Kidney Failure, ChronicArteriovenous Fistulae

Keywords

Arteriovenous fistulae (AVFs)Non-maturationComputational simulation

Outcome Measures

Primary Outcomes (1)

  • Occurence of non-maturation

    Yes/No A matured AVF has minimal flow of 500 mL/min and a minimal diameter of 4 mm by six weeks after AVF creation.

    6 weeks postoperatively

Secondary Outcomes (5)

  • Occurence of high-flow complications

    6 weeks postoperatively

  • Primary patency rates

    6 and 12 months

  • Agreement between predicted and measured flow (mL/min)

    up to 6 weeks

  • Usability of the computational tool

    6 weeks

  • Functional AVF

    >6 weeks (when AVF is matured)

Study Arms (2)

Control

NO INTERVENTION

Standard care in operative planning in AVF creation, that is physical examination and extensive duplex examination of the arm vasculature carried out by an experience vascular technician.

Simulation

EXPERIMENTAL

Standard care with the intervention of advisement of the preferred AVF-configuration, based on computational model simulation for predicting postoperative flow (AVF-simulation).

Device: AVF-simulation

Interventions

AVF-simulationDEVICE

A mathematical computational tool, which is developed to calculate estimates for postoperative AVF hemodynamical changes in the upper extremity. The model is based on physical laws and calculations are carried out on patient-specific duplex measurements.

Simulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patients in which treatment of first choice is the creation of an autologous AVF.
  • Patients with adequate arteries and veins (duplex) for creation of RC-, BC- or BBAVF.
  • Patients that signed the written informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Flevoziekenhuis

Almere Stad, Flevoland, 1315RA, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079DZ, Netherlands

Location

Slingeland ziekenhuis

Doetinchem, Netherlands

Location

Catharina ziekenhuis

Eindhoven, Netherlands

Location

Zuyderland

Heerlen, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229HX, Netherlands

Location

St. Antonius ziekenhuis

Nieuwegein, Netherlands

Location

Laurentius ziekenhuis

Roermond, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

  • Zonnebeld N, Huberts W, van Loon MM, Delhaas T, Tordoir JH. Preoperative computer simulation for planning of vascular access surgery in hemodialysis patients. J Vasc Access. 2017 Mar 6;18(Suppl. 1):118-124. doi: 10.5301/jva.5000661. Epub 2017 Mar 5.

    PMID: 28297050DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Niek Zonnebeld, MD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Jan Tordoir, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Wouter Huberts, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Tammo Delhaas, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 25, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2018

Study Completion

June 1, 2019

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

NL(9)