The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

Not Applicable

Terminated

• Conditions: Arteriovenous Fistula
• Interventions: Other: Same direction cannulation; Other: Opposite direction cannulation

• Registration Number: NCT01642459
• Lead Sponsor: Dongliang Zhang, MD

Brief Summary

The investigators hypothesis that aneurysms and stenoses will be decreased if the direction of inserted arterial needle were same as the direction of blood flow, when compared to the opposite direction puncture.

Detailed Description

Native arteriovenous fistula (AVF) is the preferred access for hemodialysis, and cannulation technique is very important factors affect the outcomes of AVF. Rope-ladder cannulation is one kind of the standard puncture techniques which is used commonly in maintenance hemodialysis (MHD) patients. There are many complications for rope-ladder cannulation, such as venous aneurysm and vascular stenosis, which may induce AVF dysfunction. For the venous outflow way, there always be aneurysm followed by stenoses at the sites of needle connected with the arterial line in rope-ladder cannulation patients. The investigators hypothesis that the directions of inserted arterial needles should affect the AVF outcomes. The present prospective study will compare the outcomes of AVF between the puncture direction at arterial needle sites same as blood flow and opposite to blood flow.

Study Timeline

• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-17
• Study Start: 2012-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• MHD patients with autogenous AVF.
• Newly setup AVF in 3 months.
• Fore- or Upper arm AVF.
• Flow of >800ml/min detected by using the ultrasound dilution technique.

Exclusion Criteria

• AVF after neoplasty.
• Arteriovenous grafts.
• Anticipated live time less than one year.
• Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Same direction cannulation	Same direction cannulation	The inserted direction of arterial needle is same as the direction of blood flow.
Opposite direction cannulation	Opposite direction cannulation	The inserted direction of arterial needle is opposite to the direction of blood flow.

Primary Outcome Measures

Name	Time	Method
Prevalence of AVF aneurysm and stenosis.	12 months	Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.

Secondary Outcome Measures

Name	Time	Method
Events of AVF obstruction.	12 months	AVF obstruction and the following treatments as central venous catheters and interventions will be recorded and compared between two groups during 12 months.
Proportions of AVF dysfunction in different groups.	12 months	Compare the proportions of AVF dysfunction between two groups during 12 months.
Diameter of venous stenosis.	12 months	Measure the minimum diameter of venous stenosis by ultrasonography at month 12.
The size of venous aneurysm.	12 months	Measure the maximum size of venous aneurysm by using ultrasonography at month 12.
Percentages of unsuccessful cannulations.	12 months	Unsuccessful cannulations include mis-cannulation, cannulation ease, hematoma, more than once cannulation at arterial site.

Trial Locations

Locations (1)

Beijing Friedship Hospital; 🇨🇳 Beijing, Beijing, China