UMIN-CTR Clinical Trial

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

End-stage renal disease requiring maintenance hemodialysis

Classification by specialty

Cardiology	Nephrology	Vascular surgery
Dermatology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Department of Hemodialysis and Apheresis, The University of Tokyo Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Lifestyle Disease Coordinator Association

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2013

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2013

Year

09

Month

19

Day

Last modified on

2016

Year

03

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013800