UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044606 |
|---|---|
| Receipt number | R000050644 |
| Scientific Title | Effects of hypervolemia with hemodilution due to rapid fluid infusion on intracranial pressure in human volunteers |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2022/05/22 14:58:59 |
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Basic information
Public title
Effects of hypervolemia with hemodilution due to rapid fluid infusion on intracranial pressure in human volunteers
Acronym
Effects of rapid fluid infusion on intracranial pressure
Scientific Title
Effects of hypervolemia with hemodilution due to rapid fluid infusion on intracranial pressure in human volunteers
Scientific Title:Acronym
Effects of rapid fluid infusion on intracranial pressure
Region
| Japan |
Condition
Condition
Not applicable(healthy male volunteers, opt-out)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Rapid fluid infusion is a common intervention in intensive care or perioperative management. In our previous study, hypervolemia with hemodilution induced by rapid fluid infusion impaired dynamic cerebral autoregulation. However, the effects on intracranial pressure (ICP) remain unknown. Therefore, we estimated ICP noninvasively (nICP) to examine whether rapid fluid infusion would raise ICP.
Basic objectives2
Others
Basic objectives -Others
reanalysis of the previous data to observe physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Noninvasive ICP (nICP)
Key secondary outcomes
Cerebral artery compliance
CBF pulsatility index (PI)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control is pre-infusion measurement in a supine position.
The first intervention is that 15 mL/kg of normal saline was administered at a rate of 100 mL/min in a supine (named NS-15).
The second intervention is that an additional 15 mL/kg of normal saline at the same rate in a supine position (named NS-30, total 30mL/kg).
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participants who were taken part in the original study performed by Division of Hygiene, Department of Social Medicine, Nihon University School of Medicine in 2005. The written informed consent was obtained in the original study to investigate the effects of changes in blood volume on circulatory regulation.
Key exclusion criteria
Participants who desire withdraw from the present study via opt-out.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Iwasaki |
Organization
Nihon University School of Medicine
Division name
Department of Social Medicine, Division of Hygiene
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 | Ken-ichi |
| Middle name | |
| Last name | Iwasaki |
Organization
Nihon University School of Medicine
Division name
Department of Social Medicine, Division of Hygiene
Zip code
173-8610
Address
30-1, Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
iwasaki.kenichi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
A laboratory foundation of Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Other
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, Iabashi-ku, Tokyo
Tel
0339728111
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
| 2021 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
https://doi.org/10.3357/AMHP.6004.2022
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3357/AMHP.6004.2022
Number of participants that the trial has enrolled
12
Results
An index of intracranial pressure increased significantly in infusion stages from preinfusion. Also, cerebral blood flow velocity in MCA increased significantly. However, No significant changes were observed in cerebral artery compliance or pulsatility index.
Results date posted
| 2022 | Year | 05 | Month | 22 | Day |
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
| 2021 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 03 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 03 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050644
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| Registered date | File name |
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