UMIN-CTR Clinical Trial

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
Email	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
Email	hitomi.y@tojinkai.jp

Sponsor
Institute	Tojinkai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045769