NCT04978155

Brief Summary

Preoperative vascular mapping with echo-Doppler is acknowledged as indispensable to create an arteriovenous fistula for haemodialysis (AVF). The conditions for performing this examination are not always ideal (venous vasospasm in cool temperatures, variability of the volume status in the dialysis patient). On the other hand, the use of a loco-regional anaesthesia (LRA) results in the vasodilation of the limb thus rendering it possible to use the veins which were initially considered too small. The aim of this study is to assess the functionality of our AVF when ultrasound identification was used by the surgeon after the LRA. These results have been compared with those of the preceding year during which this identification was not implemented.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

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

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

July 9, 2021

Last Update Submit

July 15, 2021

Conditions

Keywords

Arterio-veinous fistula accesspreoperative Doppler ultrasoundmaturation access

Outcome Measures

Primary Outcomes (1)

  • Functionality of the AVF at the time of the postoperative

    An AVF is defined as functional if all the criteria of the good development of the haemodialysis access (based on the National Kidney Foundation's criteria) are present : Blood flow\>600ml, diameter over 6mm and lower depth of 6mm

    6 weeks

Secondary Outcomes (2)

  • The rate of planning change between the surgical project at the time of the consultation and the AVF that is finally placed

    During the surgery

  • Primary, assisted primary and secondary permeability of our accesses

    12 months

Study Arms (2)

Echo group

All the patients (n=90) who had an AVF creation with preoperative venous identification by the surgeon at CHU de TOULOUSE (echo group).

Diagnostic Test: Duplex ultrasound performed by the surgeon after locoregional anesthesia

Control

All the patients (n=93) who had a native AVF placed during the year 2019 without having received immediate preoperative ultrasound and therefore there was no alteration in the surgical project in relation to that planned at the time of the consultation

Interventions

Just after locoregional anesthesia, the surgeon perform a duplex ultrasound to determinate if the target vessel chosen to create the arterio-venous fistulae match with the pre-operative duplex performed during the consultation. So the plan can be changed such as more distal, more proximal creation, changing vein or artery target.

Echo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients who had an AVF creation with preoperative venous identification by the surgeon at CHU de TOULOUSE during the year 2020.

You may qualify if:

  • Native AVF access
  • During the year 2020
  • Preoperative mapping during the consultation
  • Loco-regional anesthesia

You may not qualify if:

  • Redo surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

aurelien Hostalrich

Toulouse, 31059, France

Location

Related Publications (1)

  • Hostalrich A, Boisroux T, Segal J, Lebas B, Ricco JB, Chaufour X. Assessment of Duplex Ultrasound Carried Out by the Vascular Surgeon After Locoregional Anesthesia for Preferred Arteriovenous Fistula Access. Ann Vasc Surg. 2022 Jul;83:117-123. doi: 10.1016/j.avsg.2021.11.014. Epub 2021 Dec 20.

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vascular Surgeon,MD, Principal investigator

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 27, 2021

Study Start

January 1, 2020

Primary Completion

February 1, 2021

Study Completion

July 1, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations