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

NCT ID: NCT02272374

Last Updated: 2014-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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e-AVF group

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

Group Type EXPERIMENTAL

AVF creation

Intervention Type PROCEDURE

e-TCC group

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

Group Type EXPERIMENTAL

TCC placement

Intervention Type PROCEDURE

e-AVG group

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

Group Type EXPERIMENTAL

AVG creation

Intervention Type PROCEDURE

ve-AVF group

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

Group Type EXPERIMENTAL

AVF creation

Intervention Type PROCEDURE

ve-TCC group

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

Group Type EXPERIMENTAL

TCC placement

Intervention Type PROCEDURE

ve-AVG group

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

Group Type EXPERIMENTAL

AVG creation

Intervention Type PROCEDURE

Interventions

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AVF creation

Intervention Type PROCEDURE

TCC placement

Intervention Type PROCEDURE

AVG creation

Intervention Type PROCEDURE

Other Intervention Names

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Arteriovenous fistula creation Tunneled cuffed catheter placement Arteriovenous graft creation

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

Zhongda Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Beijing Haidian Hospital

OTHER

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Changlin Mei

Professor, Director, Division of Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Changlin Mei, master

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Shanghai ChangZheng Hospital

Locations

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Shanghai Changzheng Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Xiaohong Hu, master

Role: CONTACT

+8615026520819

Other Identifiers

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CZHKI-HDVA-004

Identifier Type: -

Identifier Source: org_study_id

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