Arteriovenous FistulaNCT04270292
Arteriovenous Fistula Cannulation Practices and Dialysis Adequacy
An observational study of Arteriovenous Fistula and Hemodialysis, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial summary
Arteriovenous fistulae are preferred among methods of providing blood access for hemodialysis. For each hemodialysis treatment, the fistula is cannulated usually with two needles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula, Hemodialysis, Dialysis Adequacy
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 30 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Demiroglu Bilim University
Istanbul, Sisli, 34360
About this study
Official title: 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 One, the arterial needle, allows the blood to be withdrawn from the patient into the dialysis circuit and then it is returned by the second or venous needle.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.
Read the 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.
- Conditions
- Arteriovenous Fistula, Hemodialysis, Dialysis Adequacy
- Keywords
- Arteriovenous fistula, Antegrade direction, Dialysis adequacy, Nursing care, Cannulation practices
- Medical subject headings
- Arteriovenous Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Fistula Needle Direction
The hemodialysis nurse who cannulate the patient's fistula fill the data form. There is two options about fistula direction as antegrade or retrograde.
Measured: up to 12 weeks
Number of Cannulation Method
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.
Measured: up to 12 weeks
Number of Fistula Needle Rotated
The researchers look to the fistula needle while it inserts to the fistula. There is two options as needle rotation is yes or no.
Measured: up to 12 weeks
Number of Arterial and Venous Needle Been on the Same Line
The researchers look to the arterial and venous line whether they are the same venous line.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 May 2019
- Primary completion1 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul Demiroglu Bilim University
- Investigators
- Nurten Ozen, Asst. Prof., Principal investigator, Istanbul Demiroglu Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270292
- Sponsor's protocol ID
- P0139R00
- Status last verified
- Aug 2020
- First submitted
- 12 Feb 2020
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31151432Elias 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.
PubMed 28263032Gauly 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.
PubMed 21688239Ozen 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.
PubMed 33492745
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arteriovenous Fistula Cannulation Methods and Dialysis Adequacy: A Cross-sectional Study From Turkey
- ClinicalTrials.gov ID
- NCT04270292
- Acronym / sponsor ID
- P0139R00
- Conditions
- Arteriovenous Fistula, Hemodialysis, Dialysis Adequacy
- Keywords
- Arteriovenous fistula, Antegrade direction, Dialysis adequacy, Nursing care, Cannulation practices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 22 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31151432Coventry 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.
- Background: PubMed 28263032Elias 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.
- Background: PubMed 21688239Gauly 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.
- Derived from this study: PubMed 33492745Ozen 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.
- Individual participant dataSharing planned: No
Related trials for Arteriovenous Fistula
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurten Ozen, Asst. Prof. principal investigator
Istanbul Demiroglu Bilim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula and Hemodialysis, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Fistula Needle Direction (time frame: up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270292, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.