Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success
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.
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Yorkshire
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Hull, Yorkshire, Det Forenede Kongerige, HU3 2JZ
- Academic Vascular Surgery Unit
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients referred to vascular consultants for AV fistula formation for haemodialysis access.
- Ability to give informed written consent
- Aged over 18 at time of referral
Exclusion Criteria:
- 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).
- Inability to give informed written consent
- Aged under 18 at time of referral
- Inability to attend follow-up appointments
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Observed cohort
All patients recruited.
Observed for clinical outcomes
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary failure of access - Immediate/early thrombosis or failure to mature.
Tidsramme: within 30 days of formation
|
Failure to mature or thrombosis of fistula
|
within 30 days of formation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Duplex findings of evidence of stenosis and correlation to compliance or histological findings
Tidsramme: 6 months
|
6 months
|
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Correlation between biomechanical compliance and histological measures of pre existing venous pathology
Tidsramme: 6 months
|
6 months
|
|
Correlation between biomechanical compliance testing and clinical outcomes
Tidsramme: 6 months
|
6 months
|
|
Assisted primary and secondary patency rates at 3 and 6 months post fistula formation
Tidsramme: 6 months
|
6 months
|
|
Functional primary patency
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ian C Chetter, MBChB FRCS, University of Hull
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Access 4
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