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Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure (TACTIC)

Primary Purpose

Renal Failure, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lower eGFR for AVF construction
Higher eGFR for AVF construction
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chronic renal failure, without AVF creation;
  • Estimated glomerular filtration rate (eGFR) <15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR<20ml/min 1.73m2 for diabetic kidney disease;
  • All study subjects must agree to participate in the study and provide written informed consent.

Exclusion Criteria:

  • Patients with the history of arteriovenous graft, or central venous catheter, or peritoneal dialysis catheter placement;

  • Contraindications to AVF construction:

    • Allen's Test is positive, or arterial diameter<2 mm; venous diameter<2.5 mm or venous occlusion/stenosis.
    • Local infection.
  • Have any other uncontrolled medical condition (severe heart failure, malignancy, severe coagulation disorders ).
  • Mental illness that makes the patients unable to complete the trial.
  • Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lower eGFR for AVF creation

    Higher eGFR for AVF creation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Maturation rate of AVF
    Assessed by duplex ultrasound. A mature fistula has a flow of over 500 mL/min,is less than 0.6 cm below the surface of the skin, and has a minimal diameter of 0.6 cm
    Primary and secondary patency rate of AVF
    Assessed by duplex ultrasound

    Secondary Outcome Measures

    Maturation time of AVF
    Assessed by duplex ultrasound
    Complications of AVF
    Assessed by duplex ultrasound
    AVF creation on ventricular volumes and left ventricular remodeling
    Assessed by doppler echocardiography
    AVF creation on AVF creation on brain MRI and cognitive functions
    Cognitive functions are assessed by psychic and autonomy scores

    Full Information

    First Posted
    September 23, 2014
    Last Updated
    October 7, 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
    NCT02259296
    Brief Title
    Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
    Acronym
    TACTIC
    Official Title
    Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
    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 timing for arteriovenous fistula (AVF) creation and its effect on target organs in patients with chronic renal failure will be investigated by multicenter prospective cohort. Lower estimated glomerular filtration rate (eGFR) patients (eGFR<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney disease) and higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF creation. Maturation rate and time of AVF will be followed up in 3 months; primary and secondary patency rate of AVF, AVF construction on cardiac structure, function, encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF creation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Failure, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lower eGFR for AVF creation
    Arm Type
    Experimental
    Arm Title
    Higher eGFR for AVF creation
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Lower eGFR for AVF construction
    Other Intervention Name(s)
    late AVF construction
    Intervention Description
    Lower eGFR patients (eGFR<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction
    Intervention Type
    Procedure
    Intervention Name(s)
    Higher eGFR for AVF construction
    Other Intervention Name(s)
    early AVF construction
    Intervention Description
    Higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction
    Primary Outcome Measure Information:
    Title
    Maturation rate of AVF
    Description
    Assessed by duplex ultrasound. A mature fistula has a flow of over 500 mL/min,is less than 0.6 cm below the surface of the skin, and has a minimal diameter of 0.6 cm
    Time Frame
    3 months
    Title
    Primary and secondary patency rate of AVF
    Description
    Assessed by duplex ultrasound
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Maturation time of AVF
    Description
    Assessed by duplex ultrasound
    Time Frame
    3 months
    Title
    Complications of AVF
    Description
    Assessed by duplex ultrasound
    Time Frame
    2 years
    Title
    AVF creation on ventricular volumes and left ventricular remodeling
    Description
    Assessed by doppler echocardiography
    Time Frame
    2 years
    Title
    AVF creation on AVF creation on brain MRI and cognitive functions
    Description
    Cognitive functions are assessed by psychic and autonomy scores
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with chronic renal failure, without AVF creation; Estimated glomerular filtration rate (eGFR) <15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR<20ml/min 1.73m2 for diabetic kidney disease; All study subjects must agree to participate in the study and provide written informed consent. Exclusion Criteria: Patients with the history of arteriovenous graft, or central venous catheter, or peritoneal dialysis catheter placement; Contraindications to AVF construction: Allen's Test is positive, or arterial diameter<2 mm; venous diameter<2.5 mm or venous occlusion/stenosis. Local infection. Have any other uncontrolled medical condition (severe heart failure, malignancy, severe coagulation disorders ). Mental illness that makes the patients unable to complete the trial. Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiang Gao
    Phone
    +862181885397
    Email
    gaoxiang43100636@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Changlin Mei
    Organizational Affiliation
    Division of Nephrology, Changzheng Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure

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