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Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis (DACAPO)

Primary Purpose

Renal Failure Chronic Requiring Hemodialysis, Central Venous Catheterization, Inadequate Hemodialysis Blood Flow

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GamCath®
Arteriovenous fistula creation
GamCath®
Arteriovenous fistula creation
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure Chronic Requiring Hemodialysis focused on measuring Hemodialysis, End-Stage Kidney Disease, Central Venous Catheterization, Digital Subtraction Angiography

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic renal failure requiring hemodialysis.
  • No medical history of central vena catheterization.
  • Maintenance hemodialysis after central vena catheterization.
  • Signed informed consent.

Exclusion Criteria:

  • Had been performed central venous puncture or catheterization before.
  • Can not use heparin.
  • Refused to sign the informed consent.
  • Advanced cancer patients.
  • With or will take arteriovenous fistula surgery in right arm.
  • Other inappropriate situation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    internal jugular vein catheterization

    femoral vein catheterization

    Arm Description

    900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation.

    500 patients will be received temporary central vena catheterization in femoral vein with non-cuff GamCath® catheter, which are unsuitable for right internal jugular vein catheterization.They will undergo AVF creation.

    Outcomes

    Primary Outcome Measures

    Bloodstream infection due to central venous catheter
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Central venous catheter exit site infection
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Inadequate hemodialysis blood flow
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Central venous catheter thrombosis
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    venous thrombosis
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    venous stenosis
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Duration time of non-cuff catheter
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.

    Secondary Outcome Measures

    Long term occurrence of venous stenosis
    CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months.
    Effects on ECG
    ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months.
    Safety Evaluation
    adverse event or serious adverse event

    Full Information

    First Posted
    September 23, 2014
    Last Updated
    October 9, 2014
    Sponsor
    Shanghai Changzheng Hospital
    Collaborators
    First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02264964
    Brief Title
    Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis
    Acronym
    DACAPO
    Official Title
    Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Changzheng Hospital
    Collaborators
    First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Failure Chronic Requiring Hemodialysis, Central Venous Catheterization, Inadequate Hemodialysis Blood Flow, Venous Stenosis, Venous Thrombosis, Infection Due to Central Venous Catheter, Central Venous Catheter Thrombosis
    Keywords
    Hemodialysis, End-Stage Kidney Disease, Central Venous Catheterization, Digital Subtraction Angiography

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    internal jugular vein catheterization
    Arm Type
    Experimental
    Arm Description
    900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation.
    Arm Title
    femoral vein catheterization
    Arm Type
    Experimental
    Arm Description
    500 patients will be received temporary central vena catheterization in femoral vein with non-cuff GamCath® catheter, which are unsuitable for right internal jugular vein catheterization.They will undergo AVF creation.
    Intervention Type
    Device
    Intervention Name(s)
    GamCath®
    Other Intervention Name(s)
    radiopaque catheter(11F) polyurethane
    Intervention Description
    Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
    Intervention Type
    Procedure
    Intervention Name(s)
    Arteriovenous fistula creation
    Other Intervention Name(s)
    Arteriovenous fistulization, AVF creation
    Intervention Description
    500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
    Intervention Type
    Device
    Intervention Name(s)
    GamCath®
    Other Intervention Name(s)
    radiopaque catheter(11F) polyurethane with curved extension lines
    Intervention Description
    Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.
    Intervention Type
    Procedure
    Intervention Name(s)
    Arteriovenous fistula creation
    Other Intervention Name(s)
    Arteriovenous fistulization, AVF creation
    Intervention Description
    900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.
    Primary Outcome Measure Information:
    Title
    Bloodstream infection due to central venous catheter
    Description
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Time Frame
    up to 3 months
    Title
    Central venous catheter exit site infection
    Description
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Time Frame
    up to 3 months
    Title
    Inadequate hemodialysis blood flow
    Description
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Time Frame
    up to 3 months
    Title
    Central venous catheter thrombosis
    Description
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Time Frame
    up to 3 months
    Title
    venous thrombosis
    Description
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Time Frame
    up to 3 months
    Title
    venous stenosis
    Description
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Time Frame
    up to 3 months
    Title
    Duration time of non-cuff catheter
    Description
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
    Time Frame
    up to 3 months
    Secondary Outcome Measure Information:
    Title
    Long term occurrence of venous stenosis
    Description
    CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months.
    Time Frame
    6 months
    Title
    Effects on ECG
    Description
    ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months.
    Time Frame
    From baseline to 6months
    Title
    Safety Evaluation
    Description
    adverse event or serious adverse event
    Time Frame
    From baseline to 6months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic renal failure requiring hemodialysis. No medical history of central vena catheterization. Maintenance hemodialysis after central vena catheterization. Signed informed consent. Exclusion Criteria: Had been performed central venous puncture or catheterization before. Can not use heparin. Refused to sign the informed consent. Advanced cancer patients. With or will take arteriovenous fistula surgery in right arm. Other inappropriate situation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yiyi Ma, master
    Phone
    +8613661679863
    Email
    dukemm@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Changlin Mei, master
    Organizational Affiliation
    Division of Nephrology, Shanghai ChangZheng Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis

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