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NCT03645720 Clinical Trial

The Prognosis of Graft Using Plastic Cannula in Hemodialysis

End Stage Renal Failure on Dialysis Clinical Trial

Official title:
A Prospective Study of the Prognosis of Graft With Plastic Cannula in Hemodialysis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03645720
Other study ID # 2018-05-030
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 22, 2018
Est. completion date June 2019

Study information
Verified date August 2022
Source Hallym University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the complication of the puncture related complication in AVG (arteriovenous graft) such as pseudoaneurysm and hematoma, and the dialysis adequacy using plastic cannula versus metal needle in hemodialysis patients

Description:

1. Ultrasonography is performed to determine the maturity of vascular access 4 weeks after AVG creation. 2. The first puncture is performed with plastic cannula or metal needle when it is judged that the blood vessel has matured. 3. Four skilled nurses perform vascular access puncture with plastic or metal needle 4. Ultrasound are used to evaluate and record the complications related to the puncture in plastic or metal needle group every month. 5. Complications and dialysis adequacy between the two groups will be evaluated after 6 months

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2019
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - Patients receiving hemodialysis treatment using AVG Exclusion Criteria: - Age under 20 years old or over 75 years old - Abnormal skin condition using immunosuppressants such as steroids. - Skin disorder - Metal allergy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Plastic cannula
puncture using plastic cannula

Locations
Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital Anyang si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of pseudoaneurysm critical puncture related complication in AVG Incidence of pseudoaneurysm at 6 months
Secondary punctutre related complication hematoma, inflitration, thrombus Monthly for 6 months.
Secondary Dialysis adeqaucy Kt/V by serum test in two groups Monthly for 6 months.
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