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)

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) - HYBRID II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019820

Enrollment

360

Registered

2016-01-01

Start date

2017-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post cardiac arrest syndrome

Interventions

2%hydrogen+oxygen oxygen

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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 .

Design outcomes

Primary

Measure	Time frame
Rate of favorable neurological outcome (Cerebral Performance Category (CPC) 1 or 2) at 90 days	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTomoyoshi Tamura

Keio University School of Medicine Emergency and critical Care Medicine

tomoyoshitamura@keio.jp+81-3-3225-1323

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026