- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270292
Arteriovenous Fistula Cannulation Practices and Dialysis Adequacy
August 20, 2020 updated by: Nurten Ozen, Istanbul Demiroglu Bilim University
Arteriovenous Fistula Cannulation Methods and Dialysis Adequacy: A Cross-sectional Study From Turkey
Arteriovenous fistulae are preferred among methods of providing blood access for hemodialysis.
For each hemodialysis treatment, the fistula is cannulated usually with two needles.
One, the arterial needle, allows the blood to be withdrawn from the patient into the dialysis circuit and then it is returned by the second or venous needle.
The success of arteriovenous fistula cannulation is dependent on many variables and these are affect the dialysis adequacy.
Study Overview
Status
Completed
Conditions
Detailed Description
As hemodialysis prescriptions are usually three times weekly (4 to 8 h), a fistula or graft for hemodialysis will be punctured twice each dialysis treatment or at least 312 times per year.
To allow healing of the tissues damaged during each cannulation, optimal cannulation practice is required by rotation of the needle insertion sites each dialysis treatment.
Vascular access (VA) has been justly described as both the lifeline and the Achilles' heel of hemodialysis therapy, making blood purification itself possible while simultaneously often constituting a limiting factor in treatment adequacy.
Study Type
Observational
Enrollment (Actual)
164
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sisli
-
Istanbul, Sisli, Turkey, 34360
- Demiroglu Bilim University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Being on hemodialysis therapy for 4 hours a day on 3 days per week for at least 6 months and 18 and older years of age who has arteriovenous fistula
Description
Inclusion Criteria:
- 18 and older years of age
- Have arteriovenous fistula
- Being on hemodialysis therapy for 4 hours a day on 3 days per week for at least 6 months
- Volunteering to participate in the study
- Have not communication problem
Exclusion Criteria:
- Younger than 18 years old
- Not volunteering to participate in the study
- Have communication problem
- Being on shorter hemodialysis therapy for 4 hours a day on 3 days per week for at least 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Fistula Needle Direction
Time Frame: up to 12 weeks
|
The hemodialysis nurse who cannulate the patient's fistula fill the data form.
There is two options about fistula direction as antegrade or retrograde.
|
up to 12 weeks
|
|
Number of Cannulation Method
Time Frame: up to 12 weeks
|
The hemodialysis nurse who cannulate the patient's fistula fill the data form.
There is three options about cannulation method as puncture, buttonhole, and rope ladder methods.
|
up to 12 weeks
|
|
Number of Fistula Needle Rotated
Time Frame: up to 12 weeks
|
The researchers look to the fistula needle while it inserts to the fistula.
There is two options as needle rotation is yes or no.
|
up to 12 weeks
|
|
Number of Arterial and Venous Needle Been on the Same Line
Time Frame: up to 12 weeks
|
The researchers look to the arterial and venous line whether they are the same venous line.
|
up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nurten Ozen, Asst. Prof., Istanbul Demiroglu Bilim University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Coventry LL, Hosking JM, Chan DT, Coral E, Lim WH, Towell-Barnard A, Twigg DE, Rickard CM. Variables associated with successful vascular access cannulation in hemodialysis patients: a prospective cohort study. BMC Nephrol. 2019 May 31;20(1):197. doi: 10.1186/s12882-019-1373-3.
- Elias M, Nnang-Obada E, Charpentier B, Durrbach A, Beaudreuil S. Impact of arteriovenous fistula cannulation on the quality of dialysis. Hemodial Int. 2018 Jan;22(1):45-49. doi: 10.1111/hdi.12539. Epub 2017 Mar 6.
- Gauly A, Parisotto MT, Skinder A, Schoder V, Furlan A, Schuh E, Marcelli D. Vascular access cannulation in hemodialysis patients - a survey of current practice and its relation to dialysis dose. J Vasc Access. 2011 Oct-Dec;12(4):358-64. doi: 10.5301/JVA.2011.8413.
- Ozen N, Aydin Sayilan A, Sayilan S, Mut D, Akin EB, Ecder ST. Relationship between arteriovenous fistula cannulation practices and dialysis adequacy: A prospective, multicenter study. J Ren Care. 2022 Mar;48(1):41-48. doi: 10.1111/jorc.12365. Epub 2021 Jan 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2019
Primary Completion (ACTUAL)
December 1, 2019
Study Completion (ACTUAL)
January 30, 2020
Study Registration Dates
First Submitted
February 12, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (ACTUAL)
February 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 20, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0139R00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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