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

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AVF creation
TCC placement
AVG creation
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis, Arteriovenous fistula, Tunneled cuffed catheter, Arteriovenous graft, Elderly, Very elderly

Eligibility Criteria

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

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.

Sites / Locations

  • Shanghai Changzheng Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

e-AVF group

e-TCC group

e-AVG group

ve-AVF group

ve-TCC group

ve-AVG group

Arm Description

120 elderly with end stage renal disease will undergo AVF creation.

120 elderly with end stage renal disease will undergo TCC placement.

60 elderly with end stage renal disease will undergo AVG creation.

80 very elderly with end stage renal disease will undergo AVF creation.

80 very elderly with end stage renal disease will undergo TCC placement.

40 very elderly with end stage renal disease will undergo AVG creation.

Outcomes

Primary Outcome Measures

The patency rate of vascular access
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.
Effect of vascular access construction on ventricular volumes and left ventricular remodeling
Assessed by doppler echocardiography
Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function
Cognitive functions are assessed by psychic and autonomy scores

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2014
Last Updated
October 20, 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
NCT02272374
Brief Title
Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China
Acronym
ACCESS-China
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Hemodialysis, Arteriovenous fistula, Tunneled cuffed catheter, Arteriovenous graft, Elderly, Very elderly

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
e-AVF group
Arm Type
Experimental
Arm Description
120 elderly with end stage renal disease will undergo AVF creation.
Arm Title
e-TCC group
Arm Type
Experimental
Arm Description
120 elderly with end stage renal disease will undergo TCC placement.
Arm Title
e-AVG group
Arm Type
Experimental
Arm Description
60 elderly with end stage renal disease will undergo AVG creation.
Arm Title
ve-AVF group
Arm Type
Experimental
Arm Description
80 very elderly with end stage renal disease will undergo AVF creation.
Arm Title
ve-TCC group
Arm Type
Experimental
Arm Description
80 very elderly with end stage renal disease will undergo TCC placement.
Arm Title
ve-AVG group
Arm Type
Experimental
Arm Description
40 very elderly with end stage renal disease will undergo AVG creation.
Intervention Type
Procedure
Intervention Name(s)
AVF creation
Other Intervention Name(s)
Arteriovenous fistula creation
Intervention Type
Procedure
Intervention Name(s)
TCC placement
Other Intervention Name(s)
Tunneled cuffed catheter placement
Intervention Type
Procedure
Intervention Name(s)
AVG creation
Other Intervention Name(s)
Arteriovenous graft creation
Primary Outcome Measure Information:
Title
The patency rate of vascular access
Description
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.
Time Frame
2 years
Title
Effect of vascular access construction on ventricular volumes and left ventricular remodeling
Description
Assessed by doppler echocardiography
Time Frame
2 years
Title
Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function
Description
Cognitive functions are assessed by psychic and autonomy scores
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Complications of vascular access
Description
Described as %.Complications including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.
Time Frame
2 years
Title
Cost-effectiveness of different vascular access
Description
Described as $.The cost including medical expenses and non-medical expenses.
Time Frame
2 years
Title
Hospitalization rate due to vascular access.
Time Frame
2 years
Title
Mortality due to vascular access
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohong Hu, master
Phone
+8615026520819
Email
huxiaohong8305@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, master
Organizational Affiliation
Division of Nephrology, Shanghai ChangZheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China

12. IPD Sharing Statement

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Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China

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