NCT01642459

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

July 12, 2012

Last Update Submit

May 19, 2015

Conditions

Keywords

arteriovenous fistulahemodialysisaneurysmvascular stenosiscannulation

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

EXPERIMENTAL

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

Other: Same direction cannulation

Opposite direction cannulation

ACTIVE COMPARATOR

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

Other: Opposite direction cannulation

Interventions

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

Same direction cannulation

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

Opposite direction cannulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Arteriovenous FistulaAneurysm

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dongliang Zhang, Doctor

    Kidney Disease Faculty of Capital Medical University

    STUDY CHAIR
  • Wenying Cui, Bachelor

    Nephrology Department of Beijing Friendship Hospital

    STUDY DIRECTOR

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

Locations