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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

July 12, 2012
October 12, 2012
September 2012
April 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01642459 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Arteriovenous Fistula
  • Other: Same direction cannulation
    The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.
  • Other: Opposite direction cannulation
    The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.
  • Experimental: Same direction cannulation
    The inserted direction of arterial needle is same as the direction of blood flow.
    Intervention: Other: Same direction cannulation
  • Active Comparator: Opposite direction cannulation
    The inserted direction of arterial needle is opposite to the direction of blood flow.
    Intervention: Other: Opposite direction cannulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01642459
2012-0107
Yes
Dongliang Zhang, MD, Capital Medical University
Dongliang Zhang, MD
Not Provided
Study Chair: Dongliang Zhang, Doctor Kidney Disease Faculty of Capital Medical University
Study Director: Wenying Cui, Bachelor Nephrology Department of Beijing Friendship Hospital
Capital Medical University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP