Arteriovenous fistula cannulation in haemodialysis patients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN27841616

Enrollment

140

Registered

2010-04-29

Start date

2007-10-22

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Renal and Urogenital

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Unable or unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame
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 a	—

Measure

Time frame

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 a

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026