Study Stopped
The patients enrolled are limited.
The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMay 20, 2015
May 1, 2015
7 months
July 12, 2012
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of AVF aneurysm and stenosis.
Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.
12 months
Secondary Outcomes (5)
Proportions of AVF dysfunction in different groups.
12 months
The size of venous aneurysm.
12 months
Diameter of venous stenosis.
12 months
Percentages of unsuccessful cannulations.
12 months
Events of AVF obstruction.
12 months
Study Arms (2)
Same direction cannulation
EXPERIMENTALThe inserted direction of arterial needle is same as the direction of blood flow.
Opposite direction cannulation
ACTIVE COMPARATORThe inserted direction of arterial needle is opposite to the direction of blood flow.
Interventions
The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.
The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Friedship Hospital
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dongliang Zhang, Doctor
Kidney Disease Faculty of Capital Medical University
- STUDY DIRECTOR
Wenying Cui, Bachelor
Nephrology Department of Beijing Friendship Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associated professer
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 17, 2012
Study Start
September 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
May 20, 2015
Record last verified: 2015-05