NCT01536548

Brief Summary

Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a "button-hole" technique is increasingly recommended. By using the same two sites for cannulation there are reports of less risk of complications and less pain for the patient. However, button-hole cannulation can be difficult for the dialysis nurse, and failing cannulations can damage the AV fistula and increase patient discomfort. The investigators therefore will test whether a simple marking on the skin of the direction and angle of cannulation used in each specific patient could improve the probability of a successful and painfree cannulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

February 16, 2012

Last Update Submit

September 30, 2020

Conditions

Chronic Kidney DiseaseKidney Failure

Keywords

hemodialysiscannulationAV-fistulabuttonhole technique

Outcome Measures

Primary Outcomes (1)

  • Percentage of successful cannulations

    A successful cannulation is defined as being able to insert a blunt needle in both canals at the first attempt.

    8 weeks

Secondary Outcomes (3)

  • Difficulty of cannulation

    8 weeks

  • Fear of cannulation

    8 weeks

  • Pain at cannulation

    8 weeks

Study Arms (2)

Skin drawing

EXPERIMENTAL
Procedure: Skin drawing

No skin drawing

ACTIVE COMPARATOR
Procedure: No skin drawing

Interventions

Skin drawingPROCEDURE

Mark direction and angle for cannulation with a pencil on the skin

Skin drawing
No skin drawingPROCEDURE

Standard practice; i.e. no marks on skin to help find correct direction and angle for introducing needles

No skin drawing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic kidney disease
  • hemodialysis
  • arteriovenous fistula
  • established buttonhole technique
  • informed consent signed

You may not qualify if:

  • child
  • minor
  • not speaking Norwegian
  • not willing to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Haukeland Universitetssykehus

Bergen, Norway

Location

Bodø Sykehus

Bodø, Norway

Location

Vestre Viken Sykehus

Drammen, Norway

Location

Kristiansund Sykehus

Kristiansund, Norway

Location

Sykehuset Innlandet

Lillehammer, Norway

Location

St Olavs Hospital

Orkanger, Norway

Location

Akershus Universitetssykehus

Oslo, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

  • Rønning MI, Benshop P , Hallan S. Direction and angle-assisted cannulation of AV-fistula in hemodialysis patients - a rancomized controlled study. 2016; Oral presentation for the Vascular Access Society of America, Chicago 2016, abstract 1.1.4.8

    BACKGROUND

  • Ronning MI, Benschop WP, Ovrehus MA, Hultstrom M, Hallan SI. Direction- and Angle-Assisted Buttonhole Cannulation of Arteriovenous Fistula in Hemodialysis Patients: A Multicenter Randomized Controlled Trial. Kidney Med. 2021 Dec 1;4(2):100393. doi: 10.1016/j.xkme.2021.10.006. eCollection 2022 Feb.

    PMID: 35243305DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicRenal InsufficiencyArteriovenous Fistula

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Officials

  • Stein Hallan, PhD MD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

NO(8)