Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation

NCT04017806 | Unknown

• 1 other identifier: N201801091
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Arteriovenous Fistula

Keywords

arteriovenous fistula maturation; End stage renal disease; luminal pressure

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study is spontaneous AVF maturation.

  Spontaneous AVF maturation, which is defined as successful AVF puncture in hemodialysis for 6 consecutive sessions without any interventional procedure within 2 months.

  2 months

Secondary Outcomes (1)

• The secondary outcome is assisted AVF mature.

  2 months

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who receives surgical anastomosis of hemodialysis AVF will be included, whether the patient is a pre-dialysis patient, fresh uremic patient or who already on dialysis treatment.

You may qualify if:

• Patients with hemodialysis who receiving AVF.
• AVF created at both radial and brachial arteries

You may not qualify if:

• Patients at age \<20 years old
• Patients who are unconscious or unable to sign the inform consent
• Patient in whom native AVF creation is shifted to arteriovenous graft placement

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Taipei, 116, Taiwan

RECRUITING

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MeSH Terms

Conditions

Arteriovenous Fistula; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Chung-te Liu, MD

  Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

  STUDY DIRECTOR

Central Study Contacts

Chung-te Liu, MD

CONTACT

886-970746583; 96320@wtmu.edu.tw

Te-I Chang, MD

CONTACT

886-970746671; 103164@w.tmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: July 12, 2019
• Study Start: September 19, 2018
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: July 17, 2019

Record last verified: 2018-09

Locations

TW (1)