UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of carbon dioxide on dynamic cerebral autoregulation during simulated microgravity
Title of the study (Brief title)	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	Kenichi Iwasaki
Organization	Nihon University School of Medicine
Division name	Division of Hygiene, Department of Social Medicine
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	Kenichi Iwasaki
Organization	Nihon University School of Medicine
Division name	Division of Hygiene, Department of Social Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://ingentaconnect.com/content/asma/amhp
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.
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