Unique ID issued by UMIN | UMIN000044606 |
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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 |
Effects of hypervolemia with hemodilution due to rapid fluid infusion on intracranial pressure in human volunteers
Effects of rapid fluid infusion on intracranial pressure
Effects of hypervolemia with hemodilution due to rapid fluid infusion on intracranial pressure in human volunteers
Effects of rapid fluid infusion on intracranial pressure
Japan |
Not applicable(healthy male volunteers, opt-out)
Not applicable | Adult |
Others
NO
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.
Others
reanalysis of the previous data to observe physiological changes
Noninvasive ICP (nICP)
Cerebral artery compliance
CBF pulsatility index (PI)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
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).
20 | years-old | <= |
Not applicable |
Male and Female
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.
Participants who desire withdraw from the present study via opt-out.
12
1st name | Kenichi |
Middle name | |
Last name | Iwasaki |
Nihon University School of Medicine
Department of Social Medicine, Division of Hygiene
173-8610
30-1, Oyaguchi-kamicho, Itabashi-ku, Tokyo
03-3972-8111
iwasaki.kenichi@nihon-u.ac.jp
1st name | Ken-ichi |
Middle name | |
Last name | Iwasaki |
Nihon University School of Medicine
Department of Social Medicine, Division of Hygiene
173-8610
30-1, Oyaguchi-kamicho, Itabashi-ku, Tokyo
03-3972-8111
iwasaki.kenichi@nihon-u.ac.jp
Nihon University
A laboratory foundation of Nihon University School of Medicine
Other
Nihon University School of Medicine
30-1, Oyaguchi-kamicho, Iabashi-ku, Tokyo
0339728111
med.kenjim@nihon-u.ac.jp
NO
2021 | Year | 06 | Month | 21 | Day |
https://doi.org/10.3357/AMHP.6004.2022
Published
https://doi.org/10.3357/AMHP.6004.2022
12
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.
2022 | Year | 05 | Month | 22 | Day |
Completed
2021 | Year | 05 | Month | 19 | Day |
2021 | Year | 05 | Month | 19 | Day |
2021 | Year | 06 | Month | 21 | Day |
2021 | Year | 09 | Month | 03 | Day |
2021 | Year | 09 | Month | 03 | Day |
2021 | Year | 09 | Month | 03 | Day |
2021 | Year | 09 | Month | 03 | Day |
2021 | Year | 06 | Month | 21 | Day |
2022 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050644
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