Surveillance and Proactive Intervention for Dialysis Access

NCT ID: NCT01391975

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the blood vessels. Methods of detecting narrowing are available and, more importantly, can detect narrowings before a fistula fails. It is not known whether treating these narrowings will actually improve fistula survival or if the majority can be left alone. we wish to see if we can detect such narrowings with ultrasound scanning and if early detection and treatment improves patient outcomes.

Detailed Description

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Conditions

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Renal Failure Arteriovenous Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Surveillance and proactive intervention

Group Type EXPERIMENTAL

Active ultrasound surveillance of fistula and proactive treatment of stenosis

Intervention Type PROCEDURE

Regular duplex ultrasound assessment of fistula from time of creation until 6 months post procedure with referral of all haemodynamically significant stenoses to further imaging and treatment

Control and reactive intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active ultrasound surveillance of fistula and proactive treatment of stenosis

Regular duplex ultrasound assessment of fistula from time of creation until 6 months post procedure with referral of all haemodynamically significant stenoses to further imaging and treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access.
2. Ability to give informed written consent
3. Aged over 18 at time of referral

Exclusion Criteria

1. Inability to give informed written consent
2. Aged under 18 at time of referral
3. Inability to attend follow-up appointments

Specific exclusion;

1. Previous arteriovenous access procedures in target limb
2. Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
3. Known thrombophilic or thrombotic pathology
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hull

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hull Royal Infirmary

Hull, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Access 6

Identifier Type: -

Identifier Source: org_study_id

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