UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect and Safety of Hydrogen Inhalation on Outcome Following Brain Ischemia During Post Cardiac Arrest Care: HYBRID study (Pilot study)
Title of the study (Brief title)	The Effect and Safety of H2 inhalation for patient with post cardiac arrest syndrome
Region	Japan

Condition
Condition	Post cardiac arrest syndrome
Classification by specialty	Cardiology Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test the effect and safety of hydrogen Inhalation for patient with post cardiac arrest syndrome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Frequency of adverse events including death and abnormal findings for 7 days after hospital admission
Key secondary outcomes	1.Plasma/Urine oxidative stress, Plasma cytokine, Blood hydrogen concentration 2.Survival rate at 7days, 30 days and 90 days 3.Rate of good neurological outcome (CPC 1 or 2) at 30 days and 90days

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	Other
Interventions/Control_1	Mixed gas of oxygen and 2% hydrogen
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. An age of 20 to 80 years. 2. Achieved return of spontaneous circulation. 3. Glasgow come scale >= 8. 4. Possible to receive inhalation of gas within 12 hours after return of spontaneous circulation. 5. Patient without neurological impairment before cardiac arrest event. (CPC 1 or 2) 6. SpO2 >= 94% under 50% O2 condition 7. Systolic blood pressure (SBP) >= 90 mmHg.
Key exclusion criteria	1. Known trauma (except for suffocation), acute aortic dissection, terminal of cancer 2. Do not attempt resuscitation 3. Pregnancy 4. Usage of cardio pulmonary bypass 5. Patients judged as being inappropriate for the study by investigators
Target sample size	5

Research contact person
Name of lead principal investigator	Shingo Hori
Organization	School of Medicine, Keio university
Division name	Emergency and Critical care medicine
Address	35 Shinanomachi, Shinjyuku, Tokyo, Japan
TEL	03-3225-1323
Email	shingo@z3.keio.jp

Public contact
Name of contact person	Tomoyoshi Tamura
Organization	School of Medicine, Keio university
Division name	Emergency and Critical care medicine
Address	35 Shinanomachi, Shinjyuku, Tokyo, Japan
TEL	03-3225-1323
Homepage URL
Email	tomoyoshitamura@keio.jp

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	TAIYO NIPPON SANSO Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 05 Day
Anticipated trial start date	2013 Year 11 Month 22 Day
Last follow-up date	2015 Year 04 Month 22 Day
Date of closure to data entry	2015 Year 04 Month 22 Day
Date trial data considered complete	2015 Year 04 Month 23 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/circj/80/8/80_CJ-16-0127/_article
Results	We consecutively enrolled 5 patients between January 1, 2014, and January 19, 2015. Three of the patients (60%) were male, and the average age was 65+-15 years. Collapse was witnessed for all patients; 4 patients (80%) had received bystander-performed cardiopulmonary resuscitation, 4 patients (80%) were initially in ventricular fibrillation, and 4 patients (80%) had a cardiac etiology. The time interval from collapse until return of spontaneous circulation (ROSC) was 16+-4.7 min, and the time from ROSC until the initiation of HI was 4.9+-1.2 h. All patients were successfully treated with TTM between 33 and 36 degree Celsius. Hydrogen gas inhalation (HI; 2% H2 with oxygen) was initiated through a ventilator upon ICU admission and was continued for 18 h. HI was successfully applied to all the eligible patients as scheduled. The Data and Safety Monitoring Committee reviewed all adverse events (AEs) and examined their causal relationships with events and HI, concluding that no AEs were causally related to HI. The neurological intact survival rates (ie, patients with cerebral performance category (CPC) of 1,2) were assessed at 90 days after CA. An outcome of CPC 1 had been achieved by 4 of the 5 patients. One CA patient with severe pneumonia and septic shock died of respiratory deterioration 22 h after the discontinuation of HI.
Other related information

Management information
Registered date	2013 Year 11 Month 22 Day
Last modified on	2016 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014475