NCT04270292

Brief 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. One, the arterial needle, allows the blood to be withdrawn from the patient into the dialysis circuit and then it is returned by the second or venous needle.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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 22, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

February 12, 2020

Results QC Date

March 18, 2020

Last Update Submit

August 20, 2020

Conditions

Keywords

Arteriovenous fistulaAntegrade directionDialysis adequacyNursing careCannulation practices

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    up to 12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demiroglu Bilim University

Istanbul, Sisli, 34360, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 31151432BACKGROUND
  • 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.

    PMID: 28263032BACKGROUND
  • 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.

    PMID: 21688239BACKGROUND
  • 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.

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Nurten OZEN
Organization
Demiroglu Bilim University

Study Officials

  • Nurten Ozen, Asst. Prof.

    Istanbul Demiroglu Bilim University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

May 1, 2019

Primary Completion

December 1, 2019

Study Completion

January 30, 2020

Last Updated

September 1, 2020

Results First Posted

May 22, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations