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Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation

NCT04017806 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-07-17

No results posted yet for this study

Summary

Introduction Arteriovenous fistula (AVF) is the preferred hemodialysis vascular access due to its higher patency and lower infection rate. However, its major weakness is suboptimal maturation rate. Although that substantial risk factors for AVF maturation failure have been disclosed, a modifiable risk factor remains absent. While contemporary theory for AVF maturation failure focuses on disturbed wall shear stress, complicate assumtions and measurement preclude its clinical applicability. In the process of AVF maturation, elevated luminal pressure is required for outward remodeling, however, exccessively high luminal pressure may also be ditremental to AVF maturation, which remains to be defined. This study hypothesize that higher AVF luminal pressure is harmful to its maturation and investigate its potential as a modifiable factor to improve AVF maturation.

Methods and analysis This prospective study includes patients receiving surgical creation of native AVF. The exclusion criteria include age \<20 years, inability to sign inform consent and failure to create native AVF deu to technical difficulty. Demographic and labboratory profile will be collected before AVF surgery. Vascular sonography will be performed within 1 week of AVF creation to measure the blood flow rates and diameters of AVF and its branched veins. The pressure gredient within AVF will be estimated from blood flow rates by Modified Bernoulli Equation. The primary outcome was spontaneous AVF maturation defined as provision of sufficient blood flow for hemodialysis within 2 months of its creation without any interventional procedures. The secondary outcome is assisted AVF mature, which is defined as AVF maturation within 2 months from its creation, which is aided by any interventional procedure before successful use of AVF.

Ethics and dissemination This study has been approved by the ethics committee and Institutional Review Board of Taipei Medical University.

Strengths and limitations

1. The strength of the present study is the prospective design that allows complete collection of parameters and outcomes.
2. The predictor of interest for AVF maturation is luminal pressure of AVF.
3. The study assesses hemodynamic parameters of AVF and its branched veins, including diameters, flow rates, and flow volume.
4. The luminal pressure of AVF will be estimated using Modified Bernoulli Equation.
5. The primary outcome of the study is spontaneous AVF maturation.

Conditions

  • Arteriovenous Fistula

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Chung-te Liu, MD · Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2020-05-07
Completion
2020-05-07

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017806 on ClinicalTrials.gov