Clinical Trial: Preoperative Arteriovenous Fistula Simulation Study (ShuntSimulationStudy)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized-controlled Clinical Trial for the Evaluation of the Efficacy of Computational Simulation for the Planning of Vascular Access Surgery in Hemodialysis Patients

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.

Detailed Summary:

End-stage renal disease (ESRD) is a major and growing healthcare problem associated with substantial costs. By the end of 2010 the global patient population requiring chronic renal replacement therapy (RRT) exceeds 2 million, of which approximately 90% relies on hemodialysis (HD). The number of patients dependent on RRT are expected to annually increase with 8%. Based on this figure, it is expected that in 2030, 7.3 million ESRD patients need HD treatment. To facilitate adequate HD therapy a reliable vascular access (VA) is mandatory and can be provided by either creation of an autologous arteriovenous fistula (AVF), a prosthetic arteriovenous graft (AVG) or a central venous catheter (CVC). Guidelines by the National Kidney Foundation (NKF K/DOQI Guidelines), the Vascular Access Society (Good Nephrological Practice Guidelines) and the European Dialysis and Transplant Association (European Best Practice Guidelines on vascular access) advocate the implementation of an all-autologous fistula policy to maximize the use of AVF over AVG and CVC because AVF have the best long-term patency, fewer complications and require less interventions once fully maturated. Although the implementation of preoperative ultrasonography examination for vessel assessment has reduced the number of early AVF failure by improving the selection of the most suitable vessels and site for AVF creation, short- and long-term AVF dysfunction remains the major cause of morbidity and hospitalisation in HD patients, and is therefore the major limitation for HD treatment. This dysfunction is usually associated with non-maturation of the newly created AVF or the formation of neo-intimal hyperplasia (NIH) which potentially results in decreased access flow and eventual fistula thrombosis in up to 50% of AVFs. On the other hand, the low resistance vascular traject via the AVF may lead to impeded perfusion of the extremity distally of the AV anastomosis resulting
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Occurence of non-maturation [ Time Frame: 6 weeks postoperatively ]

Original Primary Outcome: Occurence of non-maturation [ Time Frame: 6 weeks postoperatively ]

Current Secondary Outcome:

• Occurence of high-flow complications [ Time Frame: 6 weeks postoperatively ]

  Yes/No

  High flow complications considered are hemodialysis access induced distal ischemia (HAIDI) and heart failure. To classify for a high-flow complication, an AVF requires a flow reduction intervention within twelve weeks following creation. For this objective HAIDI and heart failure are not considered separately.

• Primary patency rates [ Time Frame: 6 and 12 months ]
  Intervention free period from AVF construction until an intervention is used to maintain or regain a patent vascular access.
• Agreement between predicted and measured flow (mL/min) [ Time Frame: up to 6 weeks ]
  Correlation and/or Bland-Altman plot
• Usability of the computational tool [ Time Frame: 6 weeks ]
  Qualitative assessment of the perceived benefit by surgeons in surgery planning via interviews. The interview will focus on terms of user-friendliness, reporting speed, reliability of predictions, etc.
• Functional AVF [ Time Frame: >6 weeks (when AVF is matured) ]
  AVF allows for cannulation with two needles and effective dialysis, with either dialysis blood flow >300mL/min without recirculation, or a measured kt/V ≥1.4 at the end of one of these sessions.

Original Secondary Outcome:

• Occurence of high-flow complications [ Time Frame: 6 weeks postoperatively ]

  Yes/No

  High flow complications considered are hemodialysis access induced distal ischemia (HAIDI) and heart failure. To classify for a high-flow complication, an AVF requires a flow reduction intervention within twelve weeks following creation. For this objective HAIDI and heart failure are not considered separately.

• Primary patency rates [ Time Frame: 6 and 12 months ]
  Intervention free period from AVF construction untill an intervention is used to maintain or regain a patent vascular access.
• Agreement between predicted and measured flow (mL/min) [ Time Frame: up to 6 weeks ]
  Correlation and/or Bland-Altman plot
• Usability of the computational tool [ Time Frame: 6 weeks ]
  More qualitative assessment of the perceived benefit by surgeons in surgery planning.

Information By: Maastricht University Medical Center

Dates:
Date Received: May 12, 2015
Date Started: May 2015
Date Completion: May 2019
Last Updated: November 29, 2016
Last Verified: September 2016