Clinical trial NCT01099189: Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success
Official title: A Cohort Study of the Histopathological Changes Evident in Vein Wall at the Time of Arteriovenous Dialysis Access Fistulas and the Effects of Such Changes on Biomechanical Compliance and Patient's Clinical Outcomes in a University Teaching Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Replacement Therapy
Arteriovenous Fistula
Keywords: Histology
Compliance
Dialysis
Arteriovenous access fistula
vein
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2010-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient referred for access formation

Brief summary: Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. In order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula. The fistula causes an increase in the flow of blood through the vein and the vein reacts to this by becoming bigger and thicker, making it easier to connect the patient to the machine.

The success rate for the operation is relatively low and only approximately 65 from every 100 operations is still working after a year. It is thought that one factor that may cause problems with the fistula is the ability of the vein to stretch in response to increased blood flow. Previous research has shown that veins in kidney failure patients look different to those of people whose kidneys are working when viewed under a microscope.

The investigators aim to study the structure of the vein that is used in making fistulas with a microscope and also to test it in an engineering laboratory to see how much it will stretch. The investigators hope that gaining information about the structure of the vein and its ability to stretch will help determine what it is about the vein that affects how well it works as part of a fistula. This information may help surgeons select the best possible vein in a given patient to give the best chance of a working fistula in the future.


Eligibility criteria: Inclusion Criteria:

1. Patients referred to vascular consultants for AV fistula formation for haemodialysis access.
2. Ability to give informed written consent
3. Aged over 18 at time of referral

Exclusion Criteria:

1. Veins identified on preoperative ultrasound scanning to be of a calibre too small to allow sufficient material to be obtained for biomechanical testing (\<3mm diameter).
2. Inability to give informed written consent
3. Aged under 18 at time of referral
4. Inability to attend follow-up appointments

Primary outcomes:
measure: Primary failure of access - Immediate/early thrombosis or failure to mature.
timeFrame: within 30 days of formation
Secondary outcomes:
measure: Duplex findings of evidence of stenosis and correlation to compliance or histological findings
timeFrame: 6 months
measure: Correlation between biomechanical compliance and histological measures of pre existing venous pathology
timeFrame: 6 months
measure: Correlation between biomechanical compliance testing and clinical outcomes
timeFrame: 6 months
measure: Assisted primary and secondary patency rates at 3 and 6 months post fistula formation
timeFrame: 6 months
measure: Functional primary patency
timeFrame: 6 months
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Academic Vascular Surgery Unit
state: Yorkshire
Study officials:
affiliation: University of Hull
name: Ian C Chetter, MBChB FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012 Mar;55(3):849-55. doi: 10.1016/j.jvs.2011.07.095. Epub 2011 Nov 8.