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

Study Overview
=================
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.

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

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Procedure: AVF creation
* Procedure: TCC placement
* Procedure: AVG creation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-AVF group<br>120 elderly with end stage renal disease will undergo AVF creation. | Procedure: AVF creation<br> <br> * Other names: Arteriovenous fistula creation;|
| Experimental: e-TCC group<br>120 elderly with end stage renal disease will undergo TCC placement. | Procedure: TCC placement<br> <br> * Other names: Tunneled cuffed catheter placement;|
| Experimental: e-AVG group<br>60 elderly with end stage renal disease will undergo AVG creation. | Procedure: AVG creation<br> <br> * Other names: Arteriovenous graft creation;|
| Experimental: ve-AVF group<br>80 very elderly with end stage renal disease will undergo AVF creation. | Procedure: AVF creation<br> <br> * Other names: Arteriovenous fistula creation;|
| Experimental: ve-TCC group<br>80 very elderly with end stage renal disease will undergo TCC placement. | Procedure: TCC placement<br> <br> * Other names: Tunneled cuffed catheter placement;|
| Experimental: ve-AVG group<br>40 very elderly with end stage renal disease will undergo AVG creation. | Procedure: AVG creation<br> <br> * Other names: Arteriovenous graft creation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 
| Effect of vascular access construction on ventricular volumes and left ventricular remodeling | Assessed by doppler echocardiography | 2 years | 
| Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function | Cognitive functions are assessed by psychic and autonomy scores | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Arteriovenous fistula, Tunneled cuffed catheter, Arteriovenous graft, Elderly, Very elderly