Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China (ACCESS-China)
October 20, 2014 updated by: Changlin Mei, Shanghai Changzheng Hospital
Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China :a Multicenter Prospective Cohort Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China, 200003
- Shanghai Changzheng Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The elderly and very elderly with end stage renal disease.
- Estimated glomerular filtration rate (eGFR) <20ml/min*1.73m2
- All study subjects agree to participate in the study and provide written informed consent.
Exclusion Criteria:
- Patients' life expectancy is less than 2 years.
- Mental illness that makes the patients unable to complete the trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: e-AVF group
120 elderly with end stage renal disease will undergo AVF creation.
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Other Names:
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Experimental: e-TCC group
120 elderly with end stage renal disease will undergo TCC placement.
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Other Names:
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Experimental: e-AVG group
60 elderly with end stage renal disease will undergo AVG creation.
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Other Names:
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Experimental: ve-AVF group
80 very elderly with end stage renal disease will undergo AVF creation.
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Other Names:
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Experimental: ve-TCC group
80 very elderly with end stage renal disease will undergo TCC placement.
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Other Names:
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Experimental: ve-AVG group
40 very elderly with end stage renal disease will undergo AVG creation.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The patency rate of vascular access
Time Frame: 2 years
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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.
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2 years
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Effect of vascular access construction on ventricular volumes and left ventricular remodeling
Time Frame: 2 years
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Assessed by doppler echocardiography
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2 years
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Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function
Time Frame: 2 years
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Cognitive functions are assessed by psychic and autonomy scores
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Complications of vascular access
Time Frame: 2 years
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Described as %.Complications including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.
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2 years
|
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Cost-effectiveness of different vascular access
Time Frame: 2 years
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Described as $.The cost including medical expenses and non-medical expenses.
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2 years
|
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Hospitalization rate due to vascular access.
Time Frame: 2 years
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2 years
|
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Mortality due to vascular access
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Changlin Mei, master, Division of Nephrology, Shanghai ChangZheng Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
October 20, 2014
First Posted (Estimate)
October 22, 2014
Study Record Updates
Last Update Posted (Estimate)
October 22, 2014
Last Update Submitted That Met QC Criteria
October 20, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CZHKI-HDVA-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.