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Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath

Primary Purpose

Port-a-cath Occlusion, Normal Saline, Heparin Lock

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Normal Saline Flush 20 ml
Normal Saline Flush 10 ml
Heparin Flush (1000 USP, 10ml)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Port-a-cath Occlusion

Eligibility Criteria

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

Inclusion Criteria: Non-pediatric inpatients over 20 years of age with PAC placed for any disease and who need medication during hospitalization. Exclusion Criteria: History of PAC obstruction, continuous high volume drip via PAC, taking anticoagulant or antiplatelet agents, abnormal blood coagulation, pregnancy or contraceptive use, specified flushing solution by case

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Normal saline 20 ml

    Normal saline 10 ml

    usual care (heparin)

    Arm Description

    Outcomes

    Primary Outcome Measures

    port-a-cath occlusion
    failure to infusion fluid
    port-a-cath infection
    blood culture from port-A show bacterial growth

    Secondary Outcome Measures

    Full Information

    First Posted
    October 28, 2022
    Last Updated
    January 30, 2023
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05707936
    Brief Title
    Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath
    Official Title
    Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Purpose: An evidence implementation of a randomized controlled trial for whether there is the difference in intermittent flushing 0.9% normal saline and heparin? Design: a single-blind randomized controlled trial Method: This study is based on the 5A (Ask, Acquire, Appraise, Apply, Audit) of evidence health care step, and design randomized controlled trial for evidence implementation. We will include inpatients over 20 years-old adults in New Taipei City TuCheng Hospital, Taiwan, who need administration medicine by port-a-catcher. The sample size is 192 according to G-power software. Random allocation software has using for block randomization, would assign to group A: flushing with 0.9% normal saline 10ml, group B: flushing with 0.9% normal saline 20ml, and group C: flushing with heparin 100 USP/ml. SPSS 20.0 software for statistical analysis, mean or standard deviation, one- way ANOVA would use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Port-a-cath Occlusion, Normal Saline, Heparin Lock

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    192 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal saline 20 ml
    Arm Type
    Experimental
    Arm Title
    Normal saline 10 ml
    Arm Type
    Experimental
    Arm Title
    usual care (heparin)
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline Flush 20 ml
    Intervention Description
    Normal Saline Flush 20 ml
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline Flush 10 ml
    Intervention Description
    Normal Saline Flush 10 ml
    Intervention Type
    Drug
    Intervention Name(s)
    Heparin Flush (1000 USP, 10ml)
    Intervention Description
    Heparin Flush (1000 USP, 10ml)
    Primary Outcome Measure Information:
    Title
    port-a-cath occlusion
    Description
    failure to infusion fluid
    Time Frame
    in hospitalized (during admission), up to 12 weeks
    Title
    port-a-cath infection
    Description
    blood culture from port-A show bacterial growth
    Time Frame
    in hospitalized (during admission), up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non-pediatric inpatients over 20 years of age with PAC placed for any disease and who need medication during hospitalization. Exclusion Criteria: History of PAC obstruction, continuous high volume drip via PAC, taking anticoagulant or antiplatelet agents, abnormal blood coagulation, pregnancy or contraceptive use, specified flushing solution by case

    12. IPD Sharing Statement

    Learn more about this trial

    Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath

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