NCT01004627

Brief Summary

Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To get blood in and out of these patients it is possible to perform a surgical procedure to increase to size and durability of a vein in the arm to allow repeated needle insertion. This enlarged vein is called a fistula. There is some evidence that ultrasound scanning the blood vessels in the arm before surgery can improve the chances of a successful procedure. The investigators aim to test whether scanning all patients is better than scanning only those who are difficult to assess by physical examination alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

October 29, 2009

Last Update Submit

July 10, 2019

Conditions

End Stage Renal FailureSurgery

Keywords

fistulaultrasoundangioaccesspreoperative vein mappingHaemodialysisAngioaccess surgery

Outcome Measures

Primary Outcomes (1)

  • Primary failure of access (immediate/early thrombosis or failure to mature).

    30 days

Secondary Outcomes (5)

  • Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations

    open ended

  • Secondary patency - The interval from placement until time of patency measurement including intervening manipulations

    open ended

  • Site of fistula created

    within 1 month of recruitment

  • Functional primary patency - being the interval from the time of access placement until any intervention designed to maintain or re-establish patency or the time of measurement of patency during which the AVF provides dialysis access.

    open ended

  • Surgeon grade

    open ended

Other Outcomes (2)

  • Microparticle concentration

    open

  • Circulating tissue factor concentration

    open

Study Arms (2)

Control group - selective duplex

NO INTERVENTION

Patients will receive a duplex ultrasound only if specifically requested following physical examination.

Obligatory Duplex scan

EXPERIMENTAL

Patients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination

Procedure: Arterial and venous duplex ultrasound examination

Interventions

Arterial and venous duplex ultrasound examinationPROCEDURE

Ultrasound mapping of all blood vessels in the upper limb of interest

Obligatory Duplex scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to give informed written consent

You may not qualify if:

  • Previous arterial or venous surgery/intervention performed on target limb.
  • Known thrombophilic or thrombotic pathology.
  • Aged under 18 at time of referral
  • Inability to give informed written consent
  • Inability to attend follow up appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

Related Publications (1)

  • Smith GE, Barnes R, Chetter IC. Randomized clinical trial of selective versus routine preoperative duplex ultrasound imaging before arteriovenous fistula surgery. Br J Surg. 2014 Apr;101(5):469-74. doi: 10.1002/bjs.9435. Epub 2014 Feb 20.

    PMID: 24756913RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicFistula

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Officials

  • Ian C Chetter, MBChB FRCS MD

    Hull University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

March 1, 2010

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

GB(1)