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Comparative effect of plastic needle vs metal needle on high-convection volume hemodiafiltration

Status Approved

  • First Submitted Date

    2021/02/23

  • Registered Date

    2021/03/04

  • Last Updated Date

    2021/02/23

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005958
    Unique Protocol ID HKS 2020-03-023-002
    Public/Brief Title Comparative effect of plastic needle vs metal needle on high-convection volume hemodiafiltration
    Scientific Title Comparative effect of plastic needle vs metal needle on high-convection volume hemodiafiltration
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number HKS 2020-03-023-002
    Approval Date 2020-05-29
    Institutional Review Board Name Hallym University Kangnam Sacred Heart Hospital Institution Review Board
    Institutional Review Board Address 1, Singil-ro, Yeongdeungpo-gu, Seoul,
    Institutional Review Board Telephone 02-829-5527
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Young-Ki Lee
    Title MD, PhD
    Telephone +82-2-829-5214
    Affiliation Hallym University Medical Center-Kangnam
    Address 1, Singil-ro, Yeongdeungpo-gu, Seoul,
    Contact Person for Public Queries
    Name Do Hyoung Kim
    Title MD. PhD
    Telephone +82-2-829-5123
    Affiliation Hallym University Medical Center-Kangnam
    Address 1, Singil-ro, Yeongdeungpo-gu, Seoul,
    Contact Person for Updating Information
    Name Do Hyoung Kim
    Title MD. PhD
    Telephone +82-2-829-5123
    Affiliation Hallym University Medical Center-Kangnam
    Address 1, Singil-ro, Yeongdeungpo-gu, Seoul,
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-02-17 Actual
    Target Number of Participant 30
    Primary Completion Date 2021-12-31 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Hallym University Medical Center-Kangnam
    Recruitment Status Recruiting
    Date of First Enrollment 2021-02-17 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Hallym University Medical Center- Chuncheon
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-02-26 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Hallym University Medical Center-Kangnam
    Organization Type Medical Institute
    Project ID HKS 2020-03-023-002
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hallym University Medical Center-Kangnam
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Background and purpose: 
    An inverse relationship was demonstrated between the magnitude of the convection volume and the mortality risk. However, some doubt exists as to whether these high volumes can be achieved in routine clinical practice because of the low blood flow rate. In this study we prospectively investigated how high-convection volume HDF can be performed in patients with end-stage renal failure receiving HDF at Gangnam Sacred Heart Hospital and Chuncheon Sacred Heart Hospital, compared to metal needles when using plastic needles. 
    
    MATERIALS AND METHODS: 
    We enrolled 30 patients with hemodialysis, prospectively. In a stepwise fashion, blood flow rate, needle size and dialysis membrane were optimized as much as possible in all patients. The blood flow was gradually increased (300 → 330 mL/min; step 1 and 2), and after the needle gauge was increased from 16 G to 15 G (step 3 and 4). After changing the needle from metal to plastic needle, the blood flow and needle gauge were increased in the same way (step 5, 6, 7 and 8).
    
    Expected Results: In this study, we intend to determine whether high-convection volume HDF can be performed and to identify factors affecting high-convection volume to establish a method for implementing high convection volume HDF in clinical practice.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type /Procedure/Surgery  
    Intervention Description
    A study comparing the effects of dialysis before and after step-by-step intervention in a single group during hemodiafiltration. Control blood flow during hemodialysis (blood flow 300ml/min, 330ml/min) Step-by-step control), and mediation is performed through the selection of needle gauge (16G or 15G) and plastic needle or metal needle used for hemodialysis.
    Number of Arms 1
    Arm 1

    Arm Label

    Hemodiafiltration group before and after step application

    Target Number of Participant

    30

    Arm Type

    Others

    Arm Description

    A study comparing the effects of dialysis before and after step-by-step intervention in a single group during hemodiafiltration. Control blood flow during hemodialysis (blood flow 300ml/min, 330ml/min) Step-by-step control), and mediation is performed through the selection of needle gauge (16G or 15G) and plastic needle or metal needle used for hemodialysis.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N18.5)Chronic kidney disease, stage 5 

    End stage renal disease on hemodiafiltration
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    1) Adult patients over 18 years old
    2) Patients undergoing hemofiltration dialysis 3 times a week
    Exclusion Criteria
    1) Dialysis time is less than 4 hours
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Ratio of high-flow hemodialysis in each dialysis condition (substitution volume 21L or more)
    Timepoint
    At the time end of each stage
    Secondary Outcome(s) 1
    Outcome
    Change in Kt/V and change in beta 2 microglobulin removal rate
    Timepoint
    At the end of the final stage
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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