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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

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.