The Prognosis of Graft Using Plastic Cannula in Hemodialysis

NCT ID: NCT03645720

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2019-06-30

Brief Summary

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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

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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

Conditions

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End Stage Renal Failure on Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metal needle gruop

puncture using metal needle

Group Type NO_INTERVENTION

No interventions assigned to this group

plastic cannula

puncture using plastic cannula

Group Type EXPERIMENTAL

Plastic cannula

Intervention Type DEVICE

puncture using plastic cannula

Interventions

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Plastic cannula

puncture using plastic cannula

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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choi sun ryoung, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sun Ryoung Choi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

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Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2018-05-030

Identifier Type: -

Identifier Source: org_study_id

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