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

Sponsor
Shanghai Changzheng Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02259296
Collaborator
First Affiliated Hospital of Zhejiang University (Other), Zhongda Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other), Sichuan Provincial People's Hospital (Other), The Second Affiliated Hospital of Dalian Medical University (Other), Beijing Haidian Hospital (Other)
2,200
Enrollment
2
Arms
35
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lower eGFR for AVF construction
  • Procedure: Higher eGFR for AVF construction
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lower eGFR for AVF creation

Procedure: Lower eGFR for AVF construction
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
Other Names:
  • late AVF construction

    		•
    Active Comparator: Higher eGFR for AVF creation

    Procedure: Higher eGFR for AVF construction
    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
    Other Names:
  • early AVF construction

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maturation rate of AVF [3 months]

      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

    2. Primary and secondary patency rate of AVF [2 years]

      Assessed by duplex ultrasound

    Secondary Outcome Measures

    1. Maturation time of AVF [3 months]

      Assessed by duplex ultrasound

    2. Complications of AVF [2 years]

      Assessed by duplex ultrasound

    3. AVF creation on ventricular volumes and left ventricular remodeling [2 years]

      Assessed by doppler echocardiography

    4. AVF creation on AVF creation on brain MRI and cognitive functions [2 years]

      Cognitive functions are assessed by psychic and autonomy scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai Changzheng Hospital
    • 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

    Investigators

    • Principal Investigator: Changlin Mei, Division of Nephrology, Changzheng Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Changlin Mei, Professor, Director, Division of Nephrology, Shanghai Changzheng Hospital
    ClinicalTrials.gov Identifier:
    NCT02259296
    Other Study ID Numbers:
    • CZHKI-HDVA-001
    First Posted:
    Oct 8, 2014
    Last Update Posted:
    Oct 8, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Renal Insufficiency
    Kidney Failure, Chronic
    Arteriovenous Fistula
    Fistula

    Study Results

    No Results Posted as of Oct 8, 2014