Differential Diagnosis for the Causes of Subclavian Steal for Patients With Vascular Access in the Forearm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ling-Chih, Wu, Mennonite Christian Hospital
ClinicalTrials.gov Identifier:
NCT01263301
First received: December 16, 2010
Last updated: February 3, 2013
Last verified: February 2013
Results First Received: July 9, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Subclavian Steal
Intervention: Device: carotid duplex

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
enroll patients from Dec 2010 to July 2011. all enrolled patients have been studied by carotid duplex in Mennonite Christian hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
one patient with vascular access has been ruled out after enrollment for the subclavian artery revealed normal blood flow in duplex.

Reporting Groups
  Description
Carotid Duplex for Nonhemidialytic Patients Wtih SSS using carotid duplex to study vertebral and subclavian artery, using cuff test to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test for patients in the two groups
Carotid Duplex for Hemodialytic Patients

After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of vertebral artery and subclavian artery in the ipsilateral side of vascular access.

However, before carotid duplex, we didn't know which patients will show SSS.All 11 hemodialytic patients completed the study but only 2 showed the results of SSS. And for further analysis, we used these only 2.


Participant Flow:   Overall Study
    Carotid Duplex for Nonhemidialytic Patients Wtih SSS     Carotid Duplex for Hemodialytic Patients  
STARTED     5     11  
COMPLETED     5     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
11 hemodialytic patients particitated the study, only 2 shows SSS in carotid duplex. We analysed these 2 patients only.

Reporting Groups
  Description
Carotid Duplex for Nonhemodialytic Patients Wtih SSS using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
Carotid Duplex for Hemodialytic Patients With SSS After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
Total Total of all reporting groups

Baseline Measures
    Carotid Duplex for Nonhemodialytic Patients Wtih SSS     Carotid Duplex for Hemodialytic Patients With SSS     Total  
Number of Participants  
[units: participants]
  5     2     7  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     2     5  
>=65 years     2     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  62.6  ± 9.53     52.5  ± 0.70     59.71  ± 9.21  
Gender  
[units: participants]
     
Female     1     1     2  
Male     4     1     5  
Region of Enrollment  
[units: participants]
     
Taiwan     5     2     7  



  Outcome Measures
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1.  Primary:   Change of Subclavian Flow to Normal Flow Pattern During Cuff Test   [ Time Frame: two years ]

2.  Primary:   no Change of Subclavian Arterial Flow During Cuff Test   [ Time Frame: one year ]

3.  Primary:   Change of Vertebral Flow to Normal Flow Pattern During Cuff Test   [ Time Frame: two year ]

4.  Primary:   no Change of Vertebral Arterial Flow During Cuff Test   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
the number of the study is small, no standard technique for measurement of blood flow of vascular access


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ling-Chih Wu MD
Organization: Mennonite Christian Hospital
phone: 88638241234 ext 1810
e-mail: lingchihwu@yahoo.com


No publications provided


Responsible Party: Ling-Chih, Wu, Mennonite Christian Hospital
ClinicalTrials.gov Identifier: NCT01263301     History of Changes
Other Study ID Numbers: 10-06-024-ER
Study First Received: December 16, 2010
Results First Received: July 9, 2011
Last Updated: February 3, 2013
Health Authority: Taiwan: Department of Health