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Completed

NCT Number: NCT01004627

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

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.

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Key information

Conditions

End Stage Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Surgery Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial and venous duplex ultrasound examination

Procedure

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

Primary outcomes

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

    Time frame: 30 days

Secondary outcomes

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

    Time frame: open ended

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

    Time frame: open ended

  3. Site of fistula created

    Time frame: within 1 month of recruitment

  4. 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.

    Time frame: open ended

  5. Surgeon grade

    Time frame: open ended

Other outcomes

  1. Microparticle concentration

    Time frame: open

    Blood tests will be taken at baseline, 1, 3 and 6 months to investigate the impact of concentrations on patency

  2. Circulating tissue factor concentration

    Time frame: open

    Blood test to be taken at baseline, 1, 3 and 6 months and examined using ELISA to establish the impact of tissue factor concentrations on patency

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • University of Hull

Registry information

Official study title

A Prospective Randomized Controlled Trial of the Clinical Effectiveness of Obligatory Versus Elective Duplex Ultrasound Scanning Prior to Arteriovenous Fistula Formation for Haemodialysis Vascular Access in a University Teaching Hospital.

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 30, 2009
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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