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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04270292
Other study ID # P0139R00
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date January 30, 2020

Study information

Verified date August 2020
Source Istanbul Demiroglu Bilim University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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 One, the arterial needle, allows the blood to be withdrawn from the patient into the dialysis circuit and then it is returned by the second or venous needle.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


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.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date January 30, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Turkey Demiroglu Bilim University Istanbul Sisli

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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