UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of effectiveness and clarification of the mechanism of high concentration hydrogen water intake on systemic inflammatory reaction syndrome
Acronym	Evaluation of effectiveness and clarification of the mechanism of high concentration hydrogen water intake on systemic inflammatory reaction syndrome
Scientific Title	Evaluation of effectiveness and clarification of the mechanism of high concentration hydrogen water intake on systemic inflammatory reaction syndrome
Scientific Title:Acronym	Evaluation of effectiveness and clarification of the mechanism of high concentration hydrogen water intake on systemic inflammatory reaction syndrome
Region	Japan

Condition
Condition	sepsis
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and to elucidate the mechanism of oral intake of highly concentrated hydrogen water on systemic inflammatory reactions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of intestinal microflora
Key secondary outcomes	Clinical course, infectious complications, and changes in cytokines and antioxidant-related substances during the study period

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Consume highly concentrated hydrogen water 150ml per time Have the patient take it in a few minutes using a catheter-tipped syringe directly from the gastric tube 3-4 times daily every 8 hours until 28 days after visit or until oral intake is sufficient
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	1) 20 years of age or older 2) Critically ill patients requiring ventilatory management at the time of admission to the Advanced Emergency Center 3) Meet the diagnostic criteria for sepsis
Key exclusion criteria	1) Patients who are expected to die early (within 48 hours of admission) 2) Patients who are at risk for tube administration due to gastrointestinal perforation, gastrointestinal bleeding, etc.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Ogura
Organization	Osaka University Graduate School of Medicine
Division name	Department of Traumatology and Acute Critical Medicine
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka
TEL	+81668795707
Email	ogura@hp-emerg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Shimizu
Organization	Osaka University Graduate School of Medicine
Division name	Department of Traumatology and Acute Critical Medicine
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka
TEL	+81668795707
Homepage URL
Email	shimiken@hp-emerg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Self-adjustment
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	Osaka University Graduate School of Medicine Department of Traumatology and Acute Critical Medicine
Address	2-15 Yamadaoka, Suita, Osaka
Tel	+81668795707
Email	shimiken@hp-emerg.med.osaka-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 09 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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	Preinitiation
Date of protocol fixation	2021 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 12 Day
Last modified on	2021 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051330