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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011802
Receipt No. R000013800
Scientific Title Painless effect by the skin cooling machine to hemodialysis blood access: A multicentre study.
Date of disclosure of the study information 2013/11/01
Last modified on 2016/03/19

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Basic information
Public title Painless effect by the skin cooling machine to hemodialysis blood access:
A multicentre study.
Acronym Painless effect by the skin cooling machine to hemodialysis blood access:
A multicentre study.
Scientific Title Painless effect by the skin cooling machine to hemodialysis blood access:
A multicentre study.
Scientific Title:Acronym Painless effect by the skin cooling machine to hemodialysis blood access:
A multicentre study.
Region
Japan

Condition
Condition End-stage renal disease requiring maintenance hemodialysis
Classification by specialty
Cardiology Nephrology Vascular surgery
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Blood access for hemodialysis is inevitable to severe pain. This study clarify the efficacy of skin cooling machine named MutsuSenshi(with registered trademark) to reduce the pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Painless and satisfaction using Visual Analogue Scale (VAS).
Key secondary outcomes The skin condition after puncture (redness, injury, itching); Ultrasound evaluation of shunt vasculature after the puncture; Skin temperature after using the cooling machine.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 A series of pre-puncture treatment to hemodialysis patients is as usual; such treatments include topical skin anesthesia tape.
1)Disinfection at puncture site.
2)Disinfection of the machine surface.
3)The machine temperature assigns to 21 C. Machine surface touches to the puncture site after reaching to the target temperature.
4)The machine tells the target temperature using beeper tone.
5)After that, skin temperature is measured immediately and an operator starts vascular puncture.

During one course of hemodialysis, arterial and venous site receive the same procedure.

The same patient joins three times on the routine procedure. After that, he/she receives the cooling machine procedure three times. Then, he/she receives the routine procedure.

The evaluation is VAS after the completion of all the procedure. VAS evaluation is performed by patients privately using iPad, PC, etc. and sent to the server anonymously.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients receiving maintenance hemodialysis
Key exclusion criteria 1.Patients who overreact to cold stimulation
2.Those with sensory disturbance in the limbs
3.Those with visual disturbance or hearing impairments
4.Those who are unable to communicate adequately with observers due to conditions such as consciousness disorder
5.Those with troubles when receiving vascular punctures over the last three hemodialysis treatments
6.Those with medical history which seem to influence the outcome of this study
7.Those whom responsible doctors consider as inappropriate participants
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eisei Noiri
Organization The University of Tokyo Hospital
Division name Department of Hemodialysis and Apheresis
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL +81-3-5800-8648
Email noiri-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eisei Noiri
Organization The University of Tokyo Hospital
Division name Department of Hemodialysis and Apheresis
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL +81-3-5800-8648
Homepage URL
Email noiri-tky@umin.ac.jp

Sponsor
Institute Department of Hemodialysis and Apheresis, The University of Tokyo Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Lifestyle Disease Coordinator Association
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 ①東京大学医学部附属病院(東京都): The University of Tokyo Hospital
②仁生社 江戸川病院 (東京都): Edogawa Hospital, Tokyo
③メディカルプラザ篠崎駅西口(東京都): Medical Plaza Shinozaki, Tokyo
④市立秋田総合病院(秋田県): Akita City Hospital, Akita
⑤ときわ会グループ 常磐病院(福島県): Tokiwakai Group Tokiwa Hospital, Fukushima

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://rrtjournal.biomedcentral.com/articles/10.1186/s41100-016-0022-6
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 Main results already published
Date of protocol fixation
2013 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 19 Day
Last modified on
2016 Year 03 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013800


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