title: Objectives and design of the hemodialysis fistula maturation study.
abstract: BACKGROUND
  A large proportion of newly created arteriovenous fistulas cannot be used for dialysis because they fail to mature adequately to support the hemodialysis blood circuit. The Hemodialysis Fistula Maturation (HFM) Study was designed to elucidate clinical and biological factors associated with fistula maturation outcomes.
  
  
  METHODS
  Multicenter prospective cohort study.
  
  
  METHODS
  Approximately 600 patients undergoing creation of a new hemodialysis fistula will be enrolled at 7 centers in the United States and followed up for as long as 4 years.
  
  
  METHODS
  Clinical, anatomical, biological, and process-of-care attributes identified pre-, intra-, or postoperatively.
  
  
  RESULTS
  The primary outcome is unassisted clinical maturation, defined as successful use of the fistula for dialysis for 4 weeks without maturation-enhancing procedures. Secondary outcomes include assisted clinical maturation, ultrasound-based anatomical maturation, fistula procedures, fistula abandonment, and central venous catheter use.
  
  
  METHODS
  Preoperative ultrasound arterial and venous mapping, flow-mediated and nitroglycerin-mediated brachial artery dilation, arterial pulse wave velocity, and venous distensibility; intraoperative vein tissue collection for histopathologic and molecular analyses; postoperative ultrasounds at 1 day, 2 weeks, 6 weeks, and prior to fistula intervention and initial cannulation.
  
  
  RESULTS
  Assuming complete data, no covariate adjustment, and unassisted clinical maturation of 50%, there will be 80% power to detect ORs of 1.83 and 1.61 for dichotomous predictor variables with exposure prevalences of 20% and 50%, respectively.
  
  
  CONCLUSIONS
  Exclusion of 2-stage transposition fistulas limits generalizability. The requirement for study visits may result in a cohort that is healthier than the overall population of patients undergoing fistula creation.
  
  
  CONCLUSIONS
  The HFM Study will be of sufficient size and scope to: (1) evaluate a broad range of mechanistic hypotheses, (2) identify clinical practices associated with maturation outcomes, (3) assess the predictive utility of early indicators of fistula outcome, and (4) establish targets for novel therapeutic interventions to improve fistula maturation.
authors.affiliation: Renal, Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA. Electronic address: ldember@upenn.edu.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Dember
authors.affiliation: Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.
authors.forename: Peter B
authors.initials: PB
authors.lastname: Imrey
authors.affiliation: Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.
authors.forename: Gerald J
authors.initials: GJ
authors.lastname: Beck
authors.affiliation: Nephrology and Hypertension Division, University of Utah School of Medicine, Salt Lake City, UT.
authors.forename: Alfred K
authors.initials: AK
authors.lastname: Cheung
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, WA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Himmelfarb
authors.affiliation: Division of Vascular Surgery and Endovascular Therapy, University of Florida College of Medicine, Gainesville, FL.
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Huber
authors.affiliation: Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.affiliation: Division of Nephrology and Hypertension, University of Cincinnati College of Medicine, Cincinnati, OH.
authors.forename: Prabir
authors.initials: P
authors.lastname: Roy-Chaudhury
authors.affiliation: Division of Nephrology, University of Texas Southwestern, Dallas, TX.
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Vazquez
authors.affiliation: Department of Pathology, University of Washington, Seattle, WA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Alpers
authors.affiliation: Department of Radiology, University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Michelle L
authors.initials: ML
authors.lastname: Robbin
authors.affiliation: Evans Department of Medicine and Whitaker Cardiovascular Institute, Boston University School of Medicine, Boston, MA.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Vita
authors.affiliation: Division of Epidemiology, University of Utah School of Medicine, Salt Lake City, UT.
authors.forename: Tom
authors.initials: T
authors.lastname: Greene
authors.affiliation: Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Gassman
authors.affiliation: Renal, Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Harold I
authors.initials: HI
authors.lastname: Feldman
mesh_terms: D000368:Aged; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects / Q000379:methods / Q000592:standards; D001808:Blood Vessels / Q000000981:diagnostic imaging / Q000473:pathology*; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D017063:Outcome Assessment, Health Care / Q000379:methods; D019990:Perioperative Care / Q000379:methods; D011446:Prospective Studies; D012039:Regional Blood Flow; D006435:Renal Dialysis / Q000379:methods*; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D017211:Treatment Failure; D014463:Ultrasonography; D014481:United States; D014654:Vascular Patency
keywords: Vascular access; arteriovenous fistula; observational