Trial Outcomes & Findings for Differential Diagnosis for the Causes of Subclavian Steal for Patients With Vascular Access in the Forearm (NCT NCT01263301)

Results Overview

we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

two years

Results posted on

2013-02-12

Participant Flow

enroll patients from Dec 2010 to July 2011. all enrolled patients have been studied by carotid duplex in Mennonite Christian hospital.

one patient with vascular access has been ruled out after enrollment for the subclavian artery revealed normal blood flow in duplex.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5	11
Overall Study COMPLETED	5	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carotid Duplex for Nonhemodialytic Patients Wtih SSS n=5 Participants 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 n=2 Participants 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 n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	62.6 years STANDARD_DEVIATION 9.53 • n=5 Participants	52.5 years STANDARD_DEVIATION 0.70 • n=7 Participants	59.71 years STANDARD_DEVIATION 9.21 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Taiwan	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: two years

Population: for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.

we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.

Outcome measures

Outcome measures
Measure	Normal Parcipitants With Subclavian Steal n=5 Participants we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test	Hemodialytic Patients With Subclavian Steal n=2 Participants we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
Change of Subclavian Flow to Normal Flow Pattern During Cuff Test	0 participants	2 participants

PRIMARY outcome

Timeframe: one year

Population: for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.

we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.

Outcome measures

Outcome measures
Measure	Normal Parcipitants With Subclavian Steal n=5 Participants we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test	Hemodialytic Patients With Subclavian Steal n=2 Participants we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
no Change of Subclavian Arterial Flow During Cuff Test	5 participants	0 participants

PRIMARY outcome

Timeframe: two year

Population: determined as above explained

we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.

Outcome measures

Outcome measures
Measure	Normal Parcipitants With Subclavian Steal n=5 Participants we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test	Hemodialytic Patients With Subclavian Steal n=2 Participants we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
Change of Vertebral Flow to Normal Flow Pattern During Cuff Test	0 participants	2 participants

PRIMARY outcome

Timeframe: 2 years

Population: as above explained

we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.

Outcome measures

Outcome measures
Measure	Normal Parcipitants With Subclavian Steal n=5 Participants we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test	Hemodialytic Patients With Subclavian Steal n=2 Participants we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
no Change of Vertebral Arterial Flow During Cuff Test	5 participants	0 participants

Adverse Events

Carotid Duplex for Nonhemodialytic Patients Wtih SSS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carotid Duplex for Hemodialytic Patients With SSS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ling-Chih Wu MD

Mennonite Christian Hospital

Phone: 88638241234

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place