Condition category
Surgery
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
22/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jennie King

ORCID ID

Contact details

London Road
Reading
RG1 5AN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4967

Study information

Scientific title

A randomised interventional treatment study to determine best practise of arteriovenous fistula cannulation in haemodialysis patients

Acronym

Study hypothesis

A randomised controlled trial to assess the best practice needling of the arterio-venous (AV) fistula between buttonhole method and rotating needling sites.

Ethics approval

Berkshire Research Ethics Committee approved on the 19th March 2007 (ref: 07/Q1602/1)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal

Intervention

Buttonhole method of cannulation using blunt needles versus normal rotating sites practice with sharp needles.

Follow up length: 12 months
Study entry: single Randomisation only

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

The study has been designed to determine the primary and secondary AVF patency rates at 1 year and the complication rate for each cannulation method.

Parameters to be measured:
1. 1 year AVF primary and secondary patency rates
2. AVF complication rate - haematoma formation, aneurysm formation, surgical or radiological interventions (i.e., stenoses), scar tissue, missed needles, skin infiltration, steal syndrome, clotted AVF, infection, bleeding time post needle removal, neurologic disorder, and frequency and duration of hospital admissions
3. Time to cannulation (i.e speed of setting up dialysis) (at each haemodialysis session). The speed with which a dialysis session is commenced is very important to a patient. They are usually on dialysis for at least 4 hours with extra time needed for travelling in from home, waiting to go on the haemodialysis machine, being cannulated for dialysis, coming off dialysis and then travelling home again. This makes it at least a 6 hour session three times a week – any minutes saved have an important impact on the patient!
4. Cannulation pain as measured by a validated visual analogue pain score and use of local anaesthetic. The Royal Berkshire Pain Chart was developed in 1992. The development of the pain tool was led by the Pain Forum in collaboration with the Practice Development Team and Dr. John Mackenzie (Pain Consultant) and included an extensive literature search, Delphi technique and then piloting on surgical, orthopaedic and medical wards within this Trust. The tool took at least two years to develop. The pain tool formed an important part of the pain point prevalence study (Trust-wide study) (1994) and (1995). Cannulation pain will be recorded at each dialysis session and is expected to take less than 1 minute to complete.
5. Economic analysis for each cannulation method
6. Nurse and patient satisfaction with each method
7. Clinical history: a record of medication including erythropoietin dose and ACEI usage, participant age and sex, site of AVF, previous vascular access procedures, date AVF was first needled and history of diabetes mellitus or ischaemic heart disease
8. Clinical parameters (already measured as part of routine clinical practice): adequacy of haemodialysis prescription (Kt/v), intra-dialytic haemodialysis monitoring (blood flow, Litres of blood processed, BP, AVF venous and arterial pressures) and blood parameters: Hb, C-reactive protein, haematocrit and cholesterol.

These parameters will be assessed by:
1. Review of participant's medical notes and medication lists (also recorded on the Renal Unit PROTON computer system)
2. At each dialysis session:
2.1. Cannulation pain score (patient time less than 1 minute)
2.2. Assessment by nurse and record kept:
2.2.1. Missed needle
2.2.2. Skin infiltration
2.2.3. Haematoma formation
2.2.4. Need for local anaesthesia
2.2.5. Time to cannulation
2.2.6. Bleeding time post needle removal
3. Monthly assessment (as per existing unit practice – nothing in addition except for monthly AVF photograph):
3.1. Blood tests as per normal Renal Unit practice (no additional blood tests being performed for participants in the trial). Any changes made to a participant's medication or haemodialysis prescription in response to these results would be made as part of our standard practice and guided by existing protocols by any member of the Renal Unit Multidisciplinary team.
3.2. Transonic ultrasound access blood flow monitoring (as per existing unit practice). Referral made for surgical or radiological intervention as per Unit protocol if indicated by results.
3.3. Monthly photograph of AVF (with a ruler measurement) – to assess scar tissue and aneurysm formation
4. Record made over the 1 year period:
4.1. Any radiological or surgical intervention for: Significant stenosis or clotted AVF
4.2. Frequency and duration of hospital admissions
4.3. Nurse preference for cannulation type
4.4. Infection: exit site or blood
4.5. Fistula failure - need for tunnelled dialysis catheter for haemodialysis

Secondary outcome measures

No secondary outcome measures

Overall trial start date

22/10/2007

Overall trial end date

16/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Any male/female participants (no age limits) receiving hamodialysis via AV fistula who are willing to participate

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Planned Sample Size: 140; UK Sample Size: 140

Participant exclusion criteria

Unable or unwilling to give informed consent

Recruitment start date

22/10/2007

Recruitment end date

16/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London Road
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

Royal Berkshire and Battle Hospitals NHS Trust (UK)

Sponsor details

Royal Berkshire and Battle Hospital
344 Oxford Road
Reading
RG30 1AG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.royalberkshire.nhs.uk/Default.aspx?theme=Patient

Funders

Funder type

Industry

Funder name

Nipro Europe NV - UK Branch (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23473984

Publication citations

  1. Results

    Vaux E, King J, Lloyd S, Moore J, Bailey L, Reading I, Naik R, Effect of buttonhole cannulation with a polycarbonate PEG on in-center hemodialysis fistula outcomes: a randomized controlled trial., Am. J. Kidney Dis., 2013, 62, 1, 81-88, doi: 10.1053/j.ajkd.2013.01.011.

Additional files

Editorial Notes