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The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dongliang Zhang, MD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01642459
First received: July 12, 2012
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Arteriovenous Fistula
 Other: Same direction cannulation
Other: Opposite direction cannulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Outcomes of Arteriovenous Fistula (AVF) Cannulated From Different Direction in Maintenance Hemodialysis Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Prevalence of AVF aneurysm and stenosis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.


Secondary Outcome Measures:
  • Proportions of AVF dysfunction in different groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare the proportions of AVF dysfunction between two groups during 12 months.

  • The size of venous aneurysm. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mearure the maxium size of venous aneurysm by using ultrasonagrphy at month 12.

  • Diameter of venous stenosis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measure the minimum diameter of venous stenosis by ultrasonagraphy at month 12.

  • Percentages of unsuccessful cannulations. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Unsuccessful cannulations include miscannulation, cannulation ease, heamatoma, more than once cannulation at arterial site.

  • Events of AVF obstruction. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    AVF obstrucion and the following treatments as cetral venous catheters and interventions will be recorded and compared between two groups during 12 months.


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642459

Locations
China, Beijing
Beijing Friedship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dongliang Zhang, MD, Associated professer, Capital Medical University
ClinicalTrials.gov Identifier: NCT01642459     History of Changes
Other Study ID Numbers: 2012-0107
Study First Received: July 12, 2012
Last Updated: October 12, 2012
Health Authority: China: Ethics Committee

Keywords provided by Capital Medical University:
arteriovenous fistula
hemodialysis
aneurysm
vascular stenosis
cannulation

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
 Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013