UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012381
Receipt number R000014475
Scientific Title The Effect and Safety of Hydrogen Inhalation on Outcome Following Brain Ischemia During Post Cardiac Arrest Care: HYBRID study (Pilot study)
Date of disclosure of the study information 2013/11/22
Last modified on 2016/11/02 17:07:28

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Basic information

Public title

The Effect and Safety of Hydrogen Inhalation on Outcome Following Brain Ischemia During Post Cardiac Arrest Care: HYBRID study (Pilot study)

Acronym

The Effect and Safety of H2 inhalation for patient with post cardiac arrest syndrome

Scientific Title

The Effect and Safety of Hydrogen Inhalation on Outcome Following Brain Ischemia During Post Cardiac Arrest Care: HYBRID study (Pilot study)

Scientific Title:Acronym

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

1st name
Middle name
Last name Shingo Hori

Organization

School of Medicine, Keio university

Division name

Emergency and Critical care medicine

Zip code


Address

35 Shinanomachi, Shinjyuku, Tokyo, Japan

TEL

03-3225-1323

Email

shingo@z3.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyoshi Tamura

Organization

School of Medicine, Keio university

Division name

Emergency and Critical care medicine

Zip code


Address

35 Shinanomachi, Shinjyuku, Tokyo, Japan

TEL

03-3225-1323

Homepage URL


Email

tomoyoshitamura@keio.jp


Sponsor or person

Institute

School of Medicine, Keio University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/circj/80/8/80_CJ-16-0127/_article

Number of participants that the trial has enrolled


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.

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

2013 Year 06 Month 05 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014475


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name