Indicating Direction and Angle for Cannulating of AV-fistula in Hemodialysis Patients

NCT ID: NCT01536548

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Kidney Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Skin drawing

Group Type EXPERIMENTAL

Skin drawing

Intervention Type PROCEDURE

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

No skin drawing

Group Type ACTIVE_COMPARATOR

No skin drawing

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Skin drawing

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

Intervention Type PROCEDURE

No skin drawing

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* child
* minor
* not speaking Norwegian
* not willing to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Kristiansund Hospital

OTHER

Sponsor Role collaborator

Bodø sykehus

UNKNOWN

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stein Hallan, PhD MD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haukeland Universitetssykehus

Bergen, , Norway

Site Status

Bodø Sykehus

Bodø, , Norway

Site Status

Vestre Viken Sykehus

Drammen, , Norway

Site Status

Kristiansund Sykehus

Kristiansund, , Norway

Site Status

Sykehuset Innlandet

Lillehammer, , Norway

Site Status

St Olavs Hospital

Orkanger, , Norway

Site Status

Akershus Universitetssykehus

Oslo, , Norway

Site Status

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type 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.

Reference Type DERIVED
PMID: 35243305 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011/2544

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.