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Neutrolin Versus Heparin for Locking Hemodialysis Catheters

Primary Purpose

Hemodialysis Catheter Infection, Catheter Thrombosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heparin
Neutrolin
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis Catheter Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • New hemodialysis catheter
  • Subject who will need chronic hemodialysis at least twice/week
  • Subject likely to require for at least 120 days
  • Subject or relative is likely to understand the nature of the study and sign the consent
  • Age 18 years and older

Exclusion Criteria:

  • Subject with unstable malignancy
  • Subject with liver cirrhosis with encephalopathy
  • Subject know to have allergy to heparin, citrate or traoulidine
  • Documented history of arterial thrombosis or known to have hypercoagulable state
  • Subjects with active skin infections and ulcers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Heparin group

    Neotrolin Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)
    Rate of hemodialysis catheter in each study arm

    Secondary Outcome Measures

    Proportion of hemodialysis catheters with poor flow due to thrombosis
    Rate of catheter dysfunction in each group

    Full Information

    First Posted
    January 25, 2018
    Last Updated
    March 4, 2019
    Sponsor
    King Abdullah International Medical Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03425448
    Brief Title
    Neutrolin Versus Heparin for Locking Hemodialysis Catheters
    Official Title
    Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 4, 2019 (Anticipated)
    Primary Completion Date
    October 4, 2020 (Anticipated)
    Study Completion Date
    April 4, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Abdullah International Medical Research Center

    4. Oversight

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

    5. Study Description

    Brief Summary
    Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects. Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis. This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemodialysis Catheter Infection, Catheter Thrombosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Multi-center, double-blind, randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    192 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Heparin group
    Arm Type
    Active Comparator
    Arm Title
    Neotrolin Group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Heparin
    Intervention Description
    Heparin hemodialysis catheter lock solution
    Intervention Type
    Device
    Intervention Name(s)
    Neutrolin
    Intervention Description
    Neutrolin hemodialysis catheter lock
    Primary Outcome Measure Information:
    Title
    Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)
    Description
    Rate of hemodialysis catheter in each study arm
    Time Frame
    18 month
    Secondary Outcome Measure Information:
    Title
    Proportion of hemodialysis catheters with poor flow due to thrombosis
    Description
    Rate of catheter dysfunction in each group
    Time Frame
    18 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: New hemodialysis catheter Subject who will need chronic hemodialysis at least twice/week Subject likely to require for at least 120 days Subject or relative is likely to understand the nature of the study and sign the consent Age 18 years and older Exclusion Criteria: Subject with unstable malignancy Subject with liver cirrhosis with encephalopathy Subject know to have allergy to heparin, citrate or traoulidine Documented history of arterial thrombosis or known to have hypercoagulable state Subjects with active skin infections and ulcers

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Neutrolin Versus Heparin for Locking Hemodialysis Catheters

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