The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

NCT ID: NCT01642459

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-04-30

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.

Conditions

Arteriovenous Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Same direction cannulation

The inserted direction of arterial needle is same as the direction of blood flow.

Group Type: EXPERIMENTAL

Same direction cannulation

Intervention Type: OTHER

The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.

Opposite direction cannulation

The inserted direction of arterial needle is opposite to the direction of blood flow.

Group Type: ACTIVE_COMPARATOR

Opposite direction cannulation

Intervention Type: OTHER

The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.

Interventions

Same direction cannulation

The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.

Intervention Type: OTHER

Opposite direction cannulation

The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongliang Zhang, MD

OTHER

Sponsor Role: lead

Responsible Party

Dongliang Zhang, MD

Associated professer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dongliang Zhang, Doctor

Role: STUDY_CHAIR

Kidney Disease Faculty of Capital Medical University

Wenying Cui, Bachelor

Role: STUDY_DIRECTOR

Nephrology Department of Beijing Friendship Hospital

Locations

Beijing Friedship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2012-0107

Identifier Type: -

Identifier Source: org_study_id