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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: End Stage Renal Disease

Treatments: Procedure: AVF creation; Procedure: TCC placement; Procedure: AVG creation

Study type: Interventional

Funder types: Other

Identifiers

NCT02272374

CZHKI-HDVA-004

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

500 participants in 6 patient groups

e-AVF group

Experimental group

Description:

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

Treatment:

Procedure: AVF creation

e-TCC group

Experimental group

Description:

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

Treatment:

Procedure: TCC placement

e-AVG group

Experimental group

Description:

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

Treatment:

Procedure: AVG creation

ve-AVF group

Experimental group

Description:

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

Treatment:

Procedure: AVF creation

ve-TCC group

Experimental group

Description:

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

Treatment:

Procedure: TCC placement

ve-AVG group

Experimental group

Description:

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

Treatment:

Procedure: AVG creation