UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017157 |
|---|---|
| Receipt number | 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 15:25:54 |
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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
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
iwasaki.kenichi@nihon-u.ac.jp
Sponsor or person
Institute
Division of Hygiene, Department of Social Medicine, Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
