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Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China (ACCESS-China)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272374
Recruitment Status : Unknown
Verified October 2014 by Changlin Mei, Shanghai Changzheng Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
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
Information provided by (Responsible Party):
Changlin Mei, Shanghai Changzheng Hospital

Brief Summary:
The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in China.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Procedure: AVF creation Procedure: TCC placement Procedure: AVG creation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China :a Multicenter Prospective Cohort Study
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: e-AVF group
120 elderly with end stage renal disease will undergo AVF creation.
Procedure: AVF creation
Other Name: Arteriovenous fistula creation

Experimental: e-TCC group
120 elderly with end stage renal disease will undergo TCC placement.
Procedure: TCC placement
Other Name: Tunneled cuffed catheter placement

Experimental: e-AVG group
60 elderly with end stage renal disease will undergo AVG creation.
Procedure: AVG creation
Other Name: Arteriovenous graft creation

Experimental: ve-AVF group
80 very elderly with end stage renal disease will undergo AVF creation.
Procedure: AVF creation
Other Name: Arteriovenous fistula creation

Experimental: ve-TCC group
80 very elderly with end stage renal disease will undergo TCC placement.
Procedure: TCC placement
Other Name: Tunneled cuffed catheter placement

Experimental: ve-AVG group
40 very elderly with end stage renal disease will undergo AVG creation.
Procedure: AVG creation
Other Name: Arteriovenous graft creation




Primary Outcome Measures :
  1. The patency rate of vascular access [ Time Frame: 2 years ]
    Including primary and secondary patency rate.Blood flow can be above 500 mL/min in a mature arteriovenous fistula by ultrasound scan and 4 times of body weight (Kg*4 mL/min) in a arteriovenous graft or tunneled cuffed catheter in dialysis practice.

  2. Effect of vascular access construction on ventricular volumes and left ventricular remodeling [ Time Frame: 2 years ]
    Assessed by doppler echocardiography

  3. Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function [ Time Frame: 2 years ]
    Cognitive functions are assessed by psychic and autonomy scores


Secondary Outcome Measures :
  1. Complications of vascular access [ Time Frame: 2 years ]
    Described as %.Complications including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.

  2. Cost-effectiveness of different vascular access [ Time Frame: 2 years ]
    Described as $.The cost including medical expenses and non-medical expenses.

  3. Hospitalization rate due to vascular access. [ Time Frame: 2 years ]
  4. Mortality due to vascular access [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The elderly and very elderly with end stage renal disease.
  2. Estimated glomerular filtration rate (eGFR) <20ml/min*1.73m2
  3. All study subjects agree to participate in the study and provide written informed consent.

Exclusion Criteria:

  1. Patients' life expectancy is less than 2 years.
  2. Mental illness that makes the patients unable to complete the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272374


Contacts
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Contact: Xiaohong Hu, master +8615026520819 huxiaohong8305@163.com

Locations
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China
Shanghai Changzheng Hospital
Shanghai, China, 200003
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
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Principal Investigator: Changlin Mei, master Division of Nephrology, Shanghai ChangZheng Hospital
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Responsible Party: Changlin Mei, Professor, Director, Division of Nephrology, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT02272374    
Other Study ID Numbers: CZHKI-HDVA-004
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by Changlin Mei, Shanghai Changzheng Hospital:
Hemodialysis
Arteriovenous fistula
Tunneled cuffed catheter
Arteriovenous graft
Elderly
Very elderly
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency