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The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

Primary Purpose

Arteriovenous Fistula

Status

Terminated

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Same direction cannulation

Opposite direction cannulation

About this trial

This is an interventional prevention trial for Arteriovenous Fistula focused on measuring arteriovenous fistula, hemodialysis, aneurysm, vascular stenosis, cannulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Friedship Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Same direction cannulation

Opposite direction cannulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Prevalence of AVF aneurysm and stenosis.

Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.

Secondary Outcome Measures

Proportions of AVF dysfunction in different groups.

Compare the proportions of AVF dysfunction between two groups during 12 months.

The size of venous aneurysm.

Measure the maximum size of venous aneurysm by using ultrasonography at month 12.

Diameter of venous stenosis.

Measure the minimum diameter of venous stenosis by ultrasonography at month 12.

Percentages of unsuccessful cannulations.

Unsuccessful cannulations include mis-cannulation, cannulation ease, hematoma, more than once cannulation at arterial site.

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.

Full Information

NCT ID

NCT01642459

First Posted

July 12, 2012

Last Updated

May 19, 2015

Sponsor

Dongliang Zhang, MD

1. Study Identification

Unique Protocol Identification Number

NCT01642459

Brief Title

The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Why Stopped

The patients enrolled are limited.

Study Start Date

September 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dongliang Zhang, MD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arteriovenous Fistula

Keywords

arteriovenous fistula, hemodialysis, aneurysm, vascular stenosis, cannulation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Same direction cannulation

Arm Type

Experimental

Arm Description

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

Arm Title

Opposite direction cannulation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Same direction cannulation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Opposite direction cannulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Prevalence of AVF aneurysm and stenosis.

Description

Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Proportions of AVF dysfunction in different groups.

Description

Compare the proportions of AVF dysfunction between two groups during 12 months.

Time Frame

12 months

Title

The size of venous aneurysm.

Description

Measure the maximum size of venous aneurysm by using ultrasonography at month 12.

Time Frame

12 months

Title

Diameter of venous stenosis.

Description

Measure the minimum diameter of venous stenosis by ultrasonography at month 12.

Time Frame

12 months

Title

Percentages of unsuccessful cannulations.

Description

Unsuccessful cannulations include mis-cannulation, cannulation ease, hematoma, more than once cannulation at arterial site.

Time Frame

12 months

Title

Events of AVF obstruction.

Description

AVF obstruction and the following treatments as central venous catheters and interventions will be recorded and compared between two groups during 12 months.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dongliang Zhang, Doctor

Organizational Affiliation

Kidney Disease Faculty of Capital Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wenying Cui, Bachelor

Organizational Affiliation

Nephrology Department of Beijing Friendship Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Friedship Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

12. IPD Sharing Statement

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The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

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