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

End Stage Renal Disease Clinical Trial

— ACCESS-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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02272374
• Other study ID #: CZHKI-HDVA-004
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2014
• Last updated: October 20, 2014
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2014
• Source: Shanghai Changzheng Hospital
• Contact: Xiaohong Hu, master
• Phone: +8615026520819
• Email: huxiaohong8305[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• AVF creation

• TCC placement

• AVG creation

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Effect of vascular access construction on ventricular volumes and left ventricular remodeling	Assessed by doppler echocardiography	2 years	No
Primary	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	No
Secondary	Complications of vascular access	Described as %.Complications including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.	2 years	No
Secondary	Cost-effectiveness of different vascular access	Described as $.The cost including medical expenses and non-medical expenses.	2 years	No
Secondary	Hospitalization rate due to vascular access.		2 years	No
Secondary	Mortality due to vascular access		2 years	No