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The Prognosis of Graft Using Plastic Cannula in Hemodialysis

Primary Purpose

End Stage Renal Failure on Dialysis

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Plastic cannula
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure on Dialysis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Metal needle gruop

plastic cannula

Arm Description

puncture using metal needle

puncture using plastic cannula

Outcomes

Primary Outcome Measures

Incidence of pseudoaneurysm
critical puncture related complication in AVG

Secondary Outcome Measures

punctutre related complication
hematoma, inflitration, thrombus
Dialysis adeqaucy
Kt/V by serum test in two groups

Full Information

First Posted
August 21, 2018
Last Updated
August 1, 2022
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03645720
Brief Title
The Prognosis of Graft Using Plastic Cannula in Hemodialysis
Official Title
A Prospective Study of the Prognosis of Graft With Plastic Cannula in Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
difficulty in performing study
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metal needle gruop
Arm Type
No Intervention
Arm Description
puncture using metal needle
Arm Title
plastic cannula
Arm Type
Experimental
Arm Description
puncture using plastic cannula
Intervention Type
Device
Intervention Name(s)
Plastic cannula
Intervention Description
puncture using plastic cannula
Primary Outcome Measure Information:
Title
Incidence of pseudoaneurysm
Description
critical puncture related complication in AVG
Time Frame
Incidence of pseudoaneurysm at 6 months
Secondary Outcome Measure Information:
Title
punctutre related complication
Description
hematoma, inflitration, thrombus
Time Frame
Monthly for 6 months.
Title
Dialysis adeqaucy
Description
Kt/V by serum test in two groups
Time Frame
Monthly for 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Ryoung Choi, MD,PhD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang si
State/Province
Gyeonggi-do
ZIP/Postal Code
14066
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Prognosis of Graft Using Plastic Cannula in Hemodialysis

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