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| Name | Class |
|---|---|
| University of Hull | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial and venous duplex ultrasound examination | Procedure | Ultrasound mapping of all blood vessels in the upper limb of interest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary failure of access (immediate/early thrombosis or failure to mature). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Microparticle concentration | Blood tests will be taken at baseline, 1, 3 and 6 months to investigate the impact of concentrations on patency | open |
| Circulating tissue factor concentration | 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 |
Inclusion Criteria:
General inclusion criteria;
Exclusion Criteria:
Specific exclusion criteria;
General exclusion criteria;
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| Name | Affiliation | Role |
|---|---|---|
| Ian C Chetter, MBChB FRCS MD | Hull University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24756913 | Result | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 |
| open |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |