UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045459 |
|---|---|
| Receipt number | R000051330 |
| Scientific Title | Evaluation of effectiveness and clarification of the mechanism of high concentration hydrogen water intake on systemic inflammatory reaction syndrome |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2021/09/12 15:31:11 |
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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
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
shimiken@hp-emerg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
