UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034958
Receipt No. R000039858
Scientific Title The effects of spontaneous dehydration via overnight on cerebral circulation
Date of disclosure of the study information 2018/11/21
Last modified on 2019/05/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effects of spontaneous dehydration via overnight on cerebral circulation
Acronym Dehydration and Cerebral circulation
Scientific Title The effects of spontaneous dehydration via overnight on cerebral circulation
Scientific Title:Acronym Dehydration and Cerebral circulation
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effects of spontaneous dehydration via overnight on cerebral circulations.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cerebral autoregulation after spontaneous dehydration via overnight.
Key secondary outcomes cerebral blood flow, arterial blood pressure, heart rate, stroke volume, respiratory condition, cerebral blood volume, cerebral metabolism, intracranial pressure, and cardiac circulation.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 spontaneous dehydration protocol.
Interventions/Control_2 Control protocol.
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adult consented to participate in this study.
Key exclusion criteria 1) Not satisfy selection criteria noted above.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Ken-ichi
Middle name
Last name Iwasaki
Organization Nihon University School of Medicine
Division name Division of Hygiene, Department of Social Medicine
Zip code 173-8610
Address 30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email iwasaki.kenichi@nihon-u.ac.jp

Public contact
Name of contact person
1st name Yojiro
Middle name
Last name Ogawa
Organization Nihon University School of Medicine
Division name Division of Hygiene, Department of Social Medicine
Zip code 173-8610
Address 30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL 03-3972-8111
Homepage URL
Email ogawa.yojiro@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The institutional review board of Nihon University School of Medicine
Address 30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
Tel 03-3972-8111
Email med.kenjim@nihon-u.ac.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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 21 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 23 Day
Date of IRB
2018 Year 07 Month 23 Day
Anticipated trial start date
2018 Year 11 Month 21 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039858

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.