UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040139 |
|---|---|
| Receipt number | R000045769 |
| Scientific Title | Influence of differences in vasodilatory capacity in shunt stenosis on treatment results and inspection standards |
| Date of disclosure of the study information | 2020/04/15 |
| Last modified on | 2020/04/13 09:59:28 |
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Basic information
Public title
Influence of differences in vasodilatory capacity in shunt stenosis on treatment results and inspection standards
Acronym
Vasodilator capacity of shunt stenosis
Scientific Title
Influence of differences in vasodilatory capacity in shunt stenosis on treatment results and inspection standards
Scientific Title:Acronym
Vasodilator capacity of shunt stenosis
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Vascular surgery | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined whether differences in the vasodilatory capacity of shunt stenoses affect FV, RI values, and VA prognosis.
Basic objectives2
Others
Basic objectives -Others
non
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ninety-six patients on maintenance dialysis who underwent VAIVT under echo with a stenotic cross-sectional area of less than 3.14 mm2 (2.0*2.0 mm in the case of a normal circle) were included in the study. First, subjects were classified into two groups based on the degree of vasodilatation by hemorrhage: poorly vascularized and well vascularized groups. There have been no previous reports on the degree of vasodilatation capacity in shunt stenosis as good or bad.
Statistical analysis
The study items were patient background (gender, VA type, VA construction site, age, dialysis history, VA history, and history of diabetes mellitus (DM)), non-hypertensive stenosis cross-sectional area before VAIVT, stenosis cross-sectional area during hemostasis, FV and RI before VAIVT, FV and RI after VAIVT, maximum diastolic pressure during VAIVT, stenosis dilatation rate before and after VAIVT, non-hypertensive stenosis cross-sectional area after VAIVT, number of VAIVTs in the past 3 years, and presence or absence of VA events during HD. The data from each of the two groups were compared statistically. The occurrence of a VA event was counted as a single case of poor bleeding, elevated venous pressure, or recirculation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
VAIVT
Interventions/Control_2
Flow volume, Resistance Index for Ultra sound
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ninety-six patients on maintenance dialysis who underwent VAIVT under echo with a stenotic cross-sectional area of less than 3.14 mm2 (2.0*2.0 mm in the case of a normal circle) were included in the study.
Key exclusion criteria
Unsuccessful VAIVT treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Hitomi |
Organization
Tojinkai Hospital
Division name
Department of Clinical Engineering
Zip code
612-8026
Address
83-1 iga momoyama tyo fushimi ku kyoto, Japan
TEL
0756221991
hitomi.y@tojinkai.jp
Public contact
Name of contact person
| 1st name | Yasumasa |
| Middle name | |
| Last name | Hitomi |
Organization
Tojinkai Hospital
Division name
Department of Clinical Engineering
Zip code
612-8026
Address
83-1 iga momoyama tyo fushimi ku kyoto, Japan
TEL
0756221991
Homepage URL
hitomi.y@tojinkai.jp
Sponsor or person
Institute
Tojinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Engineering, Tojinkai Hospital
Address
83-1 iga momoyama tyo fushimi ku kyoto, Japan
Tel
0756221991
hitomi.y@tojinkai.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
桃仁会病院（京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
96
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 13 | Day |
Last modified on
| 2020 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045769
