UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035141 |
|---|---|
| Receipt number | R000040037 |
| Scientific Title | Investigation for safety of hydrogen rich water administration to systemic inflammatory response |
| Date of disclosure of the study information | 2018/12/05 |
| Last modified on | 2019/06/06 09:54:07 |
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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
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
matsuura@hp-emerg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine Department of Traumatology and Acute Critical Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040037
