The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

Arteriovenous Fistula Clinical Trial

Official title:

The Outcomes of Arteriovenous Fistula (AVF) Cannulated From Different Direction in Maintenance Hemodialysis Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01642459
• Other study ID #: 2012-0107
• Status: Terminated
• Phase: N/A
• First received: July 12, 2012
• Last updated: May 19, 2015
• Start date: September 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2015
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Other:
• Same direction cannulation
The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.
• Opposite direction cannulation
The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.

Locations

Country	Name	City	State
China	Beijing Friedship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongliang Zhang, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of AVF aneurysm and stenosis.	Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.	12 months	No
Secondary	Proportions of AVF dysfunction in different groups.	Compare the proportions of AVF dysfunction between two groups during 12 months.	12 months	No
Secondary	The size of venous aneurysm.	Measure the maximum size of venous aneurysm by using ultrasonography at month 12.	12 months	No
Secondary	Diameter of venous stenosis.	Measure the minimum diameter of venous stenosis by ultrasonography at month 12.	12 months	No
Secondary	Percentages of unsuccessful cannulations.	Unsuccessful cannulations include mis-cannulation, cannulation ease, hematoma, more than once cannulation at arterial site.	12 months	Yes
Secondary	Events of AVF obstruction.	AVF obstruction and the following treatments as central venous catheters and interventions will be recorded and compared between two groups during 12 months.	12 months	No