UMIN-CTR Clinical Trial

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
Email	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
Email	iwasaki.kenichi@nihon-u.ac.jp

Sponsor
Institute	Nihon University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050644