The Prognosis of Graft Using Plastic Cannula in Hemodialysis

August 1, 2022 updated by: choi sun ryoung, MD, Hallym University Medical Center

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Anyang si, Gyeonggi-do, Korea, Republic of, 14066
        • Hallym University Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Metal needle gruop
puncture using metal needle
Experimental: plastic cannula
puncture using plastic cannula
Device: Plastic cannula
puncture using plastic cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pseudoaneurysm
Time Frame: Incidence of pseudoaneurysm at 6 months
critical puncture related complication in AVG
Incidence of pseudoaneurysm at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
punctutre related complication
Time Frame: Monthly for 6 months.
hematoma, inflitration, thrombus
Monthly for 6 months.
Dialysis adeqaucy
Time Frame: Monthly for 6 months.
Kt/V by serum test in two groups
Monthly for 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

  • Principal Investigator: Sun Ryoung Choi, MD,PhD, Hallym University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-05-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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