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

Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China :a Multicenter Prospective Cohort Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02272374
Acronym
ACCESS-China
Enrollment
500
Registered
2014-10-22
Start date
2014-10-31
Completion date
2017-12-31
Last updated
2014-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

Hemodialysis, Arteriovenous fistula, Tunneled cuffed catheter, Arteriovenous graft, Elderly, Very elderly

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.

Interventions

PROCEDUREAVF creation
PROCEDURETCC placement
PROCEDUREAVG creation

Sponsors

First Affiliated Hospital of Zhejiang University
CollaboratorOTHER
Zhongda Hospital
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
Sichuan Provincial People's Hospital
CollaboratorOTHER
The Second Affiliated Hospital of Dalian Medical University
CollaboratorOTHER
Beijing Haidian Hospital
CollaboratorOTHER
Shanghai Changzheng Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The patency rate of vascular access2 yearsIncluding 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 remodeling2 yearsAssessed by doppler echocardiography
Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function2 yearsCognitive functions are assessed by psychic and autonomy scores

Secondary

MeasureTime frameDescription
Complications of vascular access2 yearsDescribed as %.Complications including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.
Mortality due to vascular access2 years—
Cost-effectiveness of different vascular access2 yearsDescribed as $.The cost including medical expenses and non-medical expenses.
Hospitalization rate due to vascular access.2 years—

Countries

China

Contacts

Primary ContactXiaohong Hu, master
huxiaohong8305@163.com+8615026520819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026