@article{febdb3b2e8f8455091c3f26701ee202d,
title = "Study protocol for a prospective observational study to investigate the role of luminal pressure on arteriovenous fistula maturation",
abstract = "Introduction: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.",
keywords = "arteriovenous fistula (AVF), end-stage renal disease, hemodialysis, luminal pressure, vascular access",
author = "Cheng, {Ho Shun} and Chang, {Te I.} and Chen, {Cheng Hsien} and Hsu, {Shih Chang} and Hsieh, {Hui Ling} and Chen, {Chun You} and Huang, {Wen Cheng} and Sue, {Yuh Mou} and Lin, {Feng Yen} and Shih, {Chun Ming} and Chen, {Jaw Wen} and Lin, {Shing Jong} and Huang, {Po Hsun} and Liu, {Chung Te}",
note = "Funding Information: aDivision of Cardiology, Department of Internal Medicine, Wan Fang Hospital, bDepartment of Surgery, School of Medicine, College of Medicine, cDivision of Cardiovascular Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, dGraduate Institute of Biomedical Electronics and Bioinformatics, National Taiwan University, eDivision of Nephrology, Department of Internal Medicine, Wan Fang Hospital, fDivision of Nephrology, Department of Internal Medicine, Shuang Ho Hospital, gDepartment of Internal Medicine, School of Medicine, College of Medicine, hEmergency Department, Department of Emergency and Critical Medicine, Wan Fang Hospital, iDepartment of Emergency Medicine, School of Medicine, College of Medicine, Taipei Medical University, jGraduate Institute of Medical Science, National Defense Medical Center, kDepartment of Radiation Oncology, Wan Fang Hospital, lGraduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, mDivision of Cardiology and Cardiovascular Research Center, Department of Internal Medicine, Taipei Medical University Hospital, nDivision of Cardiology, Department of Medicine, Taipei Veterans General Hospital, oCardiovascular Research Center, National Yang-Ming University, pDepartment of Medical Research, Taipei Veterans General Hospital, qInstitute of Pharmacology r Institute of Clinical Medicine, National Yang-Ming University, sBoard of Directors, Taipei Medical University, Taipei, Taiwan. ∗Correspondence: Chung-Te Liu, Taipei Medical University, No. 111, Sec. 3, Xinglong Rd., Wenshan Dist., Taipei City 116, Taiwan ROC (e-mail: 96320@w.tmu.edu.tw). Funding Information: This work is supported, in part, by the research grants from the Wan Fang Hospital, Taipei Medical University (108-wf-eva-03), the Ministry of Science and Technology of Taiwan (MOST 104-2314-B-075-047); the Ministry of Science and Technology of Taiwan (MOST 106-2314-B-350-001-MY3); the Novel Bioengineering and Technological Approaches to Solve Two Major Health Problems in Taiwan program, sponsored by the Taiwan Ministry of Science and Technology Academic Excellence Program (MOST 106-2633-B-009-001); the Ministry of Health and Welfare (MOHW106-TDU-B-211-113001); Taipei Veterans General Hospital (V105C-0207, V106C-045). These funding agencies had no influence on the study design, data collection or analysis, the decision to publish, or preparation of the manuscript. Publisher Copyright: Copyright {\textcopyright} 2019 the Author(s). Published by Wolters Kluwer Health, Inc.",
year = "2019",
month = oct,
day = "1",
doi = "10.1097/MD.0000000000017238",
language = "English",
volume = "98",
journal = "Medicine (United States)",
issn = "0025-7974",
publisher = "Lippincott Williams and Wilkins",
number = "40",
}