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

  • China
      • Shanghai, China, 200003
        • Shanghai Changzheng Hospital

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:

  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.

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
Experimental: e-AVF group
120 elderly with end stage renal disease will undergo AVF creation.
Procedure: AVF creation
Other Names:
  • Arteriovenous fistula creation
Experimental: e-TCC group
120 elderly with end stage renal disease will undergo TCC placement.
Procedure: TCC placement
Other Names:
  • Tunneled cuffed catheter placement
Experimental: e-AVG group
60 elderly with end stage renal disease will undergo AVG creation.
Procedure: AVG creation
Other Names:
  • Arteriovenous graft creation
Experimental: ve-AVF group
80 very elderly with end stage renal disease will undergo AVF creation.
Procedure: AVF creation
Other Names:
  • Arteriovenous fistula creation
Experimental: ve-TCC group
80 very elderly with end stage renal disease will undergo TCC placement.
Procedure: TCC placement
Other Names:
  • Tunneled cuffed catheter placement
Experimental: ve-AVG group
40 very elderly with end stage renal disease will undergo AVG creation.
Procedure: AVG creation
Other Names:
  • Arteriovenous graft creation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
Effect of vascular access construction on ventricular volumes and left ventricular remodeling
Time Frame: 2 years
Assessed by doppler echocardiography
2 years
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of vascular access
Time Frame: 2 years
Described as %.Complications including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.
2 years
Cost-effectiveness of different vascular access
Time Frame: 2 years
Described as $.The cost including medical expenses and non-medical expenses.
2 years
Hospitalization rate due to vascular access.
Time Frame: 2 years
2 years
Mortality due to vascular access
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Collaborators

First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Zhengzhou University
Zhongda Hospital
Sichuan Provincial People's Hospital
Beijing Haidian Hospital
The Second Affiliated Hospital of Dalian Medical University

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.

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