Hemodialysis Fistula Maturation Consortium (HFM)
|Principal Investigator: AlfredCheung|
|Keywords: end stage renal disease , fistula maturation , hemodialysis access , hemodialysis , arteriovenous fistula , surgery||Department: Nephrology|
|IRB Number: 00037892||Co Investigator: LarryKraiss|
|Specialty: Vascular Surgery|
This Hemodialysis Fistula Maturation (HFM) multi-center prospective cohort study will study approximately 600 patients undergoing an AVF creation surgery and follow their peri-operative and post-operative course until clinical maturation or abandonment. The cohort will include both current dialysis patients and patients with advanced chronic kidney disease (CKD) who are nearing end-stage renal disease (ESRD). The study will be conducted under a common protocol at the 6 HFMC clinical centers (Boston University, University of Cincinnati, University of Florida at Gainesville, University of Texas Southwestern, University of Utah, and University of Washington), with participation offered to all patients meeting broad enrollment criteria.
This protocol design uses an observational cohort study in order to determine the natural history of AVF maturation in a broadly representative population of HD patients.
Ancillary Vein Study:
The NIDDK-funded Hemodialysis Fistula Maturation (HFM) study collected 554 vein samples. About 1/3 of these vein samples (184 out of 554 samples) have incomplete circumferences. We propose to use the 370 full-circumference vein samples to develop an imputation model for estimating hyperplasia in partial-circumference vein samples and address the question of the usefulness of these partial samples. Our findings could potentially contribute to the fields regarding how to deal with incomplete cross-sections.
Each subject to be included in the study must fulfill the following inclusion criteria:
1. Planned single-surgery (i.e., not two-stage) creation of an autogenous upper-extremity AVF by a surgeon participating in the study.
2. Currently on chronic dialysis, or expected to start chronic dialysis at a participating dialysis facility within three months of planned AVF creation surgery.
3. Age less than (<) 80 years if not yet on chronic hemodialysis; otherwise no upper age limit.
4. Age allowing legal consent without parental involvement which in the State of Utah is 18 years of age or older.
5. Life expectancy at least (9) nine months.
6. Ability to give informed consent.
7. Anticipated ability to meet all study protocol requirements.
Baseline Dropout Criteria:
Patients initially enrolled will be dropped from the study if either of the following occurs:
1. Critical data to be collected prior to AVF creation surgery are missing. These data are: (a) pre-operative ultrasound (US), and (b) vascular function testing. For the vascular function studies, the subject can continue to be followed as a study participant if two of the three types of vascular function studies (venous occlusion plethysmography, arterial pulse wave velocity, or brachial artery FMD/NMD) are performed; however, every effort should be made to complete all three types of vascular function studies.
2. Surgery performed by a surgeon not participating in the study, or a vascular access other than an upper extremity AVF.