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A Study of Routine Versus Selective Use of Ultrasound Scanning Prior to Haemodialysis Fistula Surgery

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NHS Trust

Status

Completed

Conditions

Surgery
End Stage Renal Failure

Treatments

Procedure: Arterial and venous duplex ultrasound examination

Study type

Interventional

Funder types

Other

Identifiers

NCT01004627
Access 1

Details and patient eligibility

About

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.

Full description

We will recruit all patients undergoing primary vascular access procedures in our unit who meet inclusion criteria. They will be randomised to either surgery based on clinical findings with duplex ultrasound only if requested by surgeon, or routine duplex ultrasound prior to surgery.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Specific inclusion criteria necessary for invitation to study participation; Patients referred to vascular consultants for primary AV fistula formation (or primary fistula in that limb) for haemodialysis access.

General inclusion criteria;

  • Ability to give informed written consent

Exclusion criteria

  • Specific exclusion criteria;

    • Previous arterial or venous surgery/intervention performed on target limb.
    • Known thrombophilic or thrombotic pathology.
    • Aged under 18 at time of referral

General exclusion criteria;

  • Inability to give informed written consent
  • Inability to attend follow up appointments

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

98 participants in 2 patient groups

Control group - selective duplex
No Intervention group
Description:
Patients will receive a duplex ultrasound only if specifically requested following physical examination.
Obligatory Duplex scan
Experimental group
Description:
Patients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination
Treatment:
Procedure: Arterial and venous duplex ultrasound examination

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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