UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034323 |
|---|---|
| Receipt number | R000039133 |
| Scientific Title | Self-intravascular shunt by the patient himself The effect of massage |
| Date of disclosure of the study information | 2019/09/29 |
| Last modified on | 2018/09/29 16:51:33 |
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Basic information
Public title
Self-intravascular shunt by the patient himself
The effect of massage
Acronym
Improvement of self-intravascular shunt patency
Percutaneous angioplasty (PTA)
Aim for extension of implementation interval
Scientific Title
Self-intravascular shunt by the patient himself
The effect of massage
Scientific Title:Acronym
Improvement of self-intravascular shunt patency
Percutaneous angioplasty (PTA)
Aim for extension of implementation interval
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
According to the data of the Japanese Society of Dialysis Medicine in 2014, approximately 320,000 people in Japan are undergoing dialysis treatment in chronic renal failure. Approximately 310,000 of them receive hemodialysis therapy. Patients undergoing hemodialysis therapy use vascular access (VA), 90% of which use autologous intravascular shunts. Many patients repeat stenosis and obstruction of the shunt and repair by percutaneous angioplasty (PTA). For this reason, various efforts are undertaken to make it possible to prolong the period of existence even a little. There are reports that the patient's own shunt massage improves the patency rate of the shunt and prolongs the practice interval of PTA. Therefore, it is the purpose of the patient to teach the method of shunt massage, to verify whether the shunt blood flow is kept better for a long time and leads to extension of the PTA execution interval.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Using a face roller once a day, massage for 1 minute toward the center side about 5 cm from the anastomotic section. There is no provision of implementation time.
Before massage begins and one week later, shunt blood flow rate is measured once a month, and change in blood flow rate is verified.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Make a shunt massage for 7 months once a day for 1 minute. Shunt echoes are measured before massage begins and one week after starting, then once a month.
Interventions/Control_2
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
Patients conducting outpatient hemodialysis at our hospital
Key exclusion criteria
nothing special
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ogihara tae |
Organization
Saitama Medical University Integrated Medical Center
Division name
Blood purification center
Zip code
Address
Saitama Prefecture Kawagoe-shi Kamoda 1981
TEL
049-228-3523
shieryou3211@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ogihara tae |
Organization
Saitama Medical University Integrated Medical Center
Division name
Blood purification center
Zip code
Address
Saitama Prefecture Kawagoe-shi Kamoda 1981
TEL
049-228-3523
Homepage URL
shieryou3211@gmail.com
Sponsor or person
Institute
Saitama Medical University Integrated Medical Center
Blood purification center
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 29 | 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
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039133
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| Registered date | File name |
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| Registered date | File name |
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