UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019820 |
|---|---|
| Receipt number | R000022898 |
| Scientific Title | Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (Phase II, multicenter, prospective, randomized, double-blinded, placebo-controlled trial) |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2023/11/02 19:01:36 |
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Basic information
Public title
Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (Phase II, multicenter, prospective, randomized, double-blinded, placebo-controlled trial)
Acronym
HYBRID II trial
Scientific Title
Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (Phase II, multicenter, prospective, randomized, double-blinded, placebo-controlled trial)
Scientific Title:Acronym
HYBRID II trial
Region
| Japan |
Condition
Condition
post cardiac arrest syndrome
Classification by specialty
| Medicine in general | Cardiology | Emergency medicine |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy and safety of hydrogen inhalation for patient with post cardiac arrest syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of favorable neurological outcome (Cerebral Performance Category (CPC) 1 or 2) at 90 days
Key secondary outcomes
1. Survival rate at 90 days
2. Survival time during 90 days
3. Modified Rankin Scale (mRS), Glasgow coma scale (GCS), and Mini-Mental State Exam (MMSE) at 90 days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
2%hydrogen+oxygen
Interventions/Control_2
oxygen
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age of 20 to 80 years.
2. Achieved return of spontaneous circulation irrespective of initial cardiac rhythm after out-of-hospital cardiac arrest.
3. Cardiac arrest of a presumed cardiac cause.
4. Sustained coma (Glasgow Coma Scale less than 8) on admission.
5. Systolic blood pressure equal to or greater than 80 mmHg irrespective of fluid loading, vasopressor and/or inotropic medication.
6. Informed consent obtained from patient's next of kin.
7. Possible to receive gas inhalation less than 6 hours after return of spontaneous circulation.
Key exclusion criteria
1. Known pre-arrest cerebral performance category (CPC) 3 or 4.
2. Known limitations in therapy and do not resuscitate order.
3. Cardiac arrest due to trauma, strangulation, intracranial hemorrhage, subarachnoid hemorrhage, cerebral infarction, acute aortic dissection, terminal cancer, or intoxication.
4. Oxygen saturation of less than 94% with 50% oxygen inhalation and adequate positive end-expiratory pressure.
5. Pregnancy.
6. Cardiopulmonary bypass use.
7. Determined as being inappropriate for the study by site investigators .
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Suzuki |
Organization
Keio University School of Medicine
Division name
Emergency and critical Care Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo, Japan
TEL
+81-3-3225-1323
suzuki@a2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Tamura |
Organization
Keio University School of Medicine
Division name
Emergency and critical Care Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo, Japan
TEL
+81-3-3225-1323
Homepage URL
tomoyoshitamura@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Taiyo Nippon Sanso Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2015 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022898
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