Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/05/2006
Date assigned
03/07/2006
Last edited
03/04/2013
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

Dr Jennifer MacRae

ORCID ID

Contact details

Foothills Hospital
Division of Nephrology
1403 29th Street
North West
Calgary
T2N 2T9
Canada
+1 403 944 2745
jennifer.macrae@calgaryhealthregion.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

STAN-B Study

Study hypothesis

Buttonhole needling of patients with an arteriovenous fistula (AVF) will be associated with a decrease in patient-perceived pain compared to standard needling.

Ethics approval

Approved by the Conjoint Health Research Ethics Board on 20/04/2006, reference number: E-20037

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Arteriovenous fistula during hemodialysis

Intervention

Buttonhole needling versus standard needling

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patient-perceived pain

Secondary outcome measures

1. AVF trauma
2. Time to hemostasis
3. Ease of needling from nursing perspective
4. AVF infection

Overall trial start date

01/07/2006

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic hemodialysis patients being treated with dialysis with an AVF
2. An AVF that has been needled consistently for at least four weeks
3. Expected to remain on dialysis for at least two months
4. Aged 18 years or older
5. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

An active AVF infection

Recruitment start date

01/07/2006

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Foothills Hospital
Calgary
T2N 2T9
Canada

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

Department of Medicine
1403 29th Street
North West
Calgary
T2N 2T9
Canada

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Calgary

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22822010

Publication citations

  1. Results

    MacRae JM, Ahmed SB, Atkar R, Hemmelgarn BR, A randomized trial comparing buttonhole with rope ladder needling in conventional hemodialysis patients., Clin J Am Soc Nephrol, 2012, 7, 10, 1632-1638, doi: 10.2215/CJN.02730312.

Additional files

Editorial Notes