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The Prognosis of Graft Using Plastic Cannula in Hemodialysis

Sponsor
Hallym University Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03645720
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
7.3
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Plastic cannula
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Study of the Prognosis of Graft With Plastic Cannula in Hemodialysis
Actual Study Start Date :
Oct 22, 2018
Anticipated Primary Completion Date :
May 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of pseudoaneurysm [Incidence of pseudoaneurysm at 6 months]

    critical puncture related complication in AVG

Secondary Outcome Measures

  1. punctutre related complication [Monthly for 6 months.]

    hematoma, inflitration, thrombus

  2. Dialysis adeqaucy [Monthly for 6 months.]

    Kt/V by serum test in two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hallym University Sacred Heart Hospital Anyang si Gyeonggi-do Korea, Republic of 14066

Sponsors and Collaborators

  • Hallym University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
choi sun ryoung, MD, Assistant professor, Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT03645720
Other Study ID Numbers:
  • 2018-05-030
First Posted:
Aug 24, 2018
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Failure, Chronic

Study Results

No Results Posted as of Aug 3, 2022