Hemodialysis Fistula Maturation Consortium

Study ID
STU 092010-099

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul
  • Parkland Health & Hospital System

Contact
Tammy Lightfoot
214-645-8265
tammy.lightfoot@utsouthwestern.edu

Principal Investigator
Miguel Vazquez

Summary

The HFMC 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. The study will be conducted under a common protocol at the six 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. extensive clinical, anatomical, physiological, and histological data will be collected using standardized procedures and definitions to identify predictors of aVF maturation. Two classes of outcomes will be observed. They are: 1) vascular features including anatomy and blood flow rate and 2) clinical adoption of the aVF as the primary dialysis vascular access. Relationships of these outcomes to one another, to baseline socio-demographic and medical history variables, to pre- and peri-operative anatomical, physiological and/or histological vascular measures, and to characteristics of the surgical procedure, will be assessed. The vascular function studies and pre-operative ultrasound will be repeated if they are performed more than 90 days before aVF creation surgery.

additional biological samples will be obtained from each patient to be stored for use in future studies to assess risk factors (e.g., genetic and protein markers) for aVF failure. Patient consent will be obtained to specifically address the collection of these specimens. Serum and plasma will be collected at two time points during the course of the study (within 28 days prior to the date of aVF creation surgery and 12 to 18 days after surgery). The pre-operative blood collection will be repeated (except for blood for Dna) if aVF creation surgery takes place more than 90 days after the original samples were obtained.The biological specimens will be shipped for long-term storage to the national institute of Diabetes and Digestive and Kidney Diseases Biosample Repository and/or Genetics Repository as appropriate for the type of sample. Details about the specimen collection, processing and shipment are described in the Manual of operations. During the course of the study, all research studies using the biorepository samples must receive the approval of the HFMC ancillary Studies Committee and follow study policies regarding ancillary studies.

Participant Eligibility

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 be started on chronic dialysis at a participating dialysis facility within three months of planned AVF creation surgery.
3.Age < 80 years if not yet on chronic hemodialysis; otherwise no upper age limit.
4.Age allowing legal consent without parental involvement (>= 18-21 years, depending on individual state regulations).
5.Life expectancy> or = nine months.
6.Ability to give informed consent.
7.Anticipated ability to meet all study protocol requirements.