UMIN-CTR Clinical Trial

Basic information
Public title	Investigation for safety of hydrogen rich water administration to systemic inflammatory response
Acronym	Investigation for safety of hydrogen rich water administration
Scientific Title	Investigation for safety of hydrogen rich water administration to systemic inflammatory response
Scientific Title:Acronym	Investigation for safety of hydrogen rich water administration
Region	Japan

Condition
Condition	sepsis after cardiopulmonary resuscitation
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to evaluate the safety of hydrogen rich water administration as a new treatment strategy for systemic inflammatory response.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	To evaluate safety, primary outcome is all adverse event including undesirable or unexpected symptoms and abnormal laboratory test value caused to the patients for one week.
Key secondary outcomes	Changes in the intestinal flora over time

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 Device,equipment
Interventions/Control_1	Administration of 150 ml hydrogen rich water (7 ppm) from the nasogastric tube once every 8 hours 3 times a day until the seventh day after admission. Administration of hydrogen rich water start when tube nutrition is started.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 16 years old and over 2) Severe patient who needs artificial ventilation management at admission 3) Patients with sepsis or after cardiopulmonary arrest resuscitation
Key exclusion criteria	1) Under 16 years old 2) Patients who are possible to die within 48 hours after admission 3) Patients who have gastrointestinal perforation or gastrointestinal bleeding which cannot receive tube nutrition. 4) Heart failure, stroke, respiratory failure due to COPD
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	Traumatology and Acute Critical Medicine
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-5707
Email	ogura@hp-emerg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Matsuura
Organization	Osaka University Graduate School of Medicine
Division name	Traumatology and Acute Critical Medicine
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-5707
Homepage URL
Email	matsuura@hp-emerg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine Department of Traumatology and Acute Critical Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2, Yamadaoka, Suita, Japan
Tel	06-6879-5111
Email	rinri@hp-crc.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	2018 Year 12 Month 05 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	Enrolling by invitation
Date of protocol fixation	2018 Year 11 Month 15 Day
Date of IRB	2018 Year 12 Month 05 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2020 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	2018 Year 12 Month 05 Day
Last modified on	2019 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040037