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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017157
Receipt No. R000019901
Scientific Title Influence of carbon dioxide on dynamic cerebral autoregulation during simulated microgravity
Date of disclosure of the study information 2015/04/17
Last modified on 2018/07/25

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Basic information
Public title Influence of carbon dioxide on dynamic cerebral autoregulation during simulated microgravity
Acronym Influence of carbon dioxide on dynamic cerebral autoregulation during simulated microgravity
Scientific Title Influence of carbon dioxide on dynamic cerebral autoregulation during simulated microgravity
Scientific Title:Acronym Influence of carbon dioxide on dynamic cerebral autoregulation during simulated microgravity
Region
Japan

Condition
Condition Healthy adult volunteers. e.g. astronauts, or exposure to carbon dioxide during head down tilt, etc.
Classification by specialty
Anesthesiology Operative medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to investigate influence of exposure to CO2 during head-down tilt on dynamic cerebral autoregulation.
Basic objectives2 Others
Basic objectives -Others The purpose is to test hypothesis that exposure to CO2 during head-down tilt will cause an additive or a synergistic effect of hypercapnia and cephalad fluid shift on dynamic cerebral autoregulation.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Gain, coherence and phase between arterial blood pressure and cerebral blood flow velocity during 10-min exposure to CO2 with head-down tilt
Key secondary outcomes cerebral blood flow velocity, pulsatility index, blood pressure variability, cerebral blood flow velocity variability, respiratory indexes, intracranial pressure, NIRS, baroreflex function, HRV

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Maneuver Other
Interventions/Control_1 exposure to CO2 (-), head-down tilt (-)
Interventions/Control_2 exposure to CO2 (+), head-down tilt (-)
Interventions/Control_3 exposure to CO2 (-), head-down tilt (+)
Interventions/Control_4 exposure to CO2 (+),head-down tilt (+)
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 Not satisfy selection criteria noted above
Target sample size 15

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

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Iwasaki
Organization Nihon University School of Medicine
Division name Division of Hygiene, Department of Social Medicine
Zip code
Address 30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Homepage URL
Email iwasaki.kenichi@nihon-u.ac.jp

Sponsor
Institute Division of Hygiene, Department of Social Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Keio University School of Medicine
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 日本大学医学部(Nihon University School of Medicine)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://ingentaconnect.com/content/asma/amhp
Number of participants that the trial has enrolled
Results
Exposure to 3%CO2 during 10 degree HDT increased gain LF, suggesting that dynamic cerebral autoregulation is impaired by a combination of hypercapnia and cephalad fluid shift. 
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
2013 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 03 Day
Last follow-up date
2015 Year 08 Month 25 Day
Date of closure to data entry
2016 Year 01 Month 31 Day
Date trial data considered complete
2016 Year 01 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information Also, cephalad fluid shift with 10 degree HDT would increase intracranial pressure.

Management information
Registered date
2015 Year 04 Month 17 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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