The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

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

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.

Study Overview

• Status: Terminated
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Other: Same direction cannulation; Other: Opposite direction cannulation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friedship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Same direction cannulation; The inserted direction of arterial needle is same as the direction of blood flow.	Other: Same direction cannulation; The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.
ACTIVE_COMPARATOR: Opposite direction cannulation; The inserted direction of arterial needle is opposite to the direction of blood flow.	Other: Opposite direction cannulation; The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of AVF aneurysm and stenosis.	Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportions of AVF dysfunction in different groups.	Compare the proportions of AVF dysfunction between two groups during 12 months.	12 months
The size of venous aneurysm.	Measure the maximum size of venous aneurysm by using ultrasonography at month 12.	12 months
Diameter of venous stenosis.	Measure the minimum diameter of venous stenosis by ultrasonography at month 12.	12 months
Percentages of unsuccessful cannulations.	Unsuccessful cannulations include mis-cannulation, cannulation ease, hematoma, more than once cannulation at arterial site.	12 months
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

Collaborators and Investigators

• Sponsor: Dongliang Zhang, MD
• Investigators: Study Chair: Dongliang Zhang, Doctor, Kidney Disease Faculty of Capital Medical University; Study Director: Wenying Cui, Bachelor, Nephrology Department of Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: July 13, 2012
• First Posted (ESTIMATE): July 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: hemodialysis; aneurysm; cannulation; arteriovenous fistula; vascular stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 2012-0107