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

Not Applicable

• Conditions: End Stage Renal Disease
• Interventions: Procedure: AVG creation; Procedure: TCC placement; Procedure: AVF creation

• Registration Number: NCT02272374
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-23
• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-20
• Last Update Submitted: 2014-10-20
• Study First Posted: 2014-10-22
• Last Update Posted: 2014-10-22
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
e-AVG group	AVG creation	60 elderly with end stage renal disease will undergo AVG creation.
ve-TCC group	TCC placement	80 very elderly with end stage renal disease will undergo TCC placement.
e-AVF group	AVF creation	120 elderly with end stage renal disease will undergo AVF creation.
ve-AVF group	AVF creation	80 very elderly with end stage renal disease will undergo AVF creation.
e-TCC group	TCC placement	120 elderly with end stage renal disease will undergo TCC placement.
ve-AVG group	AVG creation	40 very elderly with end stage renal disease will undergo AVG creation.

Primary Outcome Measures

Name	Time	Method
Effect of vascular access construction on ventricular volumes and left ventricular remodeling	2 years	Assessed by doppler echocardiography
The patency rate of vascular access	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.
Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function	2 years	Cognitive functions are assessed by psychic and autonomy scores

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China