Open AccessStudy protocol for a prospective observational study to investigate the role of luminal pressure on arteriovenous fistula maturation
Author(s) -
Ho Shun Cheng,
Te I. Chang,
Cheng Hsien Chen,
Shih Chang Hsu,
Hsiao-Yun Hsieh,
Chun You Chen,
WenHsin Huang,
Yuh Mou Sue,
Feng Yen Lin,
Chün Ming Shih,
Jaw Wen Chen,
Shing Jong Lin,
Po Hsun Huang,
Chung Te Liu
Publication year - 2019
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000017238
Subject(s) - medicine , arteriovenous fistula , hemodialysis , prospective cohort study , blood pressure , fistula , arteriovenous malformation , observational study , blood flow , cardiology , surgery , radiology
Arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis due to its higher patency and lower infection rate. However, its suboptimal maturation rate is a major weakness. Although substantial risk factors for AVF maturation failure have been disclosed, modifiable risk factors remain unknown. During the AVF maturation process, an elevated luminal pressure is required for outward remodeling; however, excessively high luminal pressure may also be detrimental to AVF maturation, which remains to be defined. We hypothesized 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 undergoing surgical creation for a native AVF. The exclusion criteria were as follows: age <20 years, inability to sign an informed consent, and failure to create a native AVF due to technical difficulties. Demographic and laboratory profiles will be collected before AVF surgery. Vascular sonography will be performed within 1 week of AVF creation to measure the diameters, flow rates, and flow volumes of AVF and its branched veins. The pressure gradient within AVF will be estimated from the blood flow rates using the modified Bernoulli equation. The primary outcome is 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 maturation, which is defined as AVF maturation within 2 months from its creation aided by any interventional procedure before the successful use of AVF. Discussion: While contemporary theory for AVF maturation failure focuses on disturbed wall shear stress, complicate assumptions and measurement preclude its clinical applicability. AVF luminal pressure, which may be manipulated pharmaceutically and surgically, may be a target to improve the outcome of AVF maturation. Trial registration: This study has been registered at the protocol registration and results system. The Protocol ID: NCT04017806.