UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044981 |
|---|---|
| Receipt number | R000051394 |
| Scientific Title | Dose effects of headward fluid shift combined with hypercapnia on cerebral blood flow regulation |
| Date of disclosure of the study information | 2021/07/28 |
| Last modified on | 2025/01/28 11:05:09 |
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Basic information
Public title
Dose effects of headward fluid shift combined with hypercapnia on cerebral blood flow regulation
Acronym
Effects of HDT and CO2 on cerebral blood flow regulation
Scientific Title
Dose effects of headward fluid shift combined with hypercapnia on cerebral blood flow regulation
Scientific Title:Acronym
Effects of HDT and CO2 on cerebral blood flow regulation
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate dose effects of headward fluid shift combined with hypercapnia on cerebral blood flow regulation.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to test hypothesis that cerebral blood flow regulation is weakened dose-dependently by headward fluid shift and hypercapnia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in middle cerebral artery blood velocity (MCAv), gain, coherence and phase between arterial blood pressure and MCAv during 10-min exposure to CO2 with head-down tilt (-5, 15, 30 degree)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
10-min exposure to 3% CO2 and -5 degree head down tilt
Interventions/Control_2
10-min exposure to 3% CO2 and -15 degree head down tilt
Interventions/Control_3
10-min exposure to 3% CO2 and -30 degree head down tilt
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult consented to participate in this study.
Key exclusion criteria
Exclusion criterion includes failure to obtain CBF velocity signals from the right MCA by TCD and having medical history regarding cardiovascular health.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| 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-Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
iwasaki.kenichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Kato |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
kato.tomokazu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1, Oyaguchi-Kamicho, Itabashi, Tokyo
Tel
03-3972-8111
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
日本大学医学部
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
https://physoc.onlinelibrary.wiley.com/doi/10.1113/EP091807
Publication of results
Published
Result
URL related to results and publications
https://physoc.onlinelibrary.wiley.com/doi/10.1113/EP091807
Number of participants that the trial has enrolled
20
Results
The transfer function gain in the low-frequency range increased significantly with -15HDT/CO2 and -30HDT/CO2, but no changes were observed with -5HDT/CO2. Phase in the range decreased significantly with all three protocols. These results of significant changes in both gain and phase during combined exposure to steep HDT (-15, -30 degree) and 3 percent CO2 inhalation suggest weakened dynamic cerebral autoregulation with the combination of moderate cephalad fluid shift and mild hypercapnia.
Results date posted
| 2025 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adults
Participant flow
All participants provided written informed consent as well as a medical history regarding cardiovascular health and were screened based on physical examinations including electrocardiography (ECG) and arterial blood pressure measurements. Participants were excluded if signals of blood velocity in the right middle cerebral artery (MCA) could not be obtained on transcranial Doppler ultrasonography (TCD) or if the individual had any history of major medical illness.
Adverse events
none
Outcome measures
end-tidal carbon dioxide pressure, heart rate, mean arterial pressure, mean blood velocity in the middle cerebral artery, respiratory rate, arterial oxygen saturation,transfer function gain, phase and coherence mean arterial pressure variability and mean blood velocity variability in the MCA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051394
