HYBRID2 trial

JRCT ID: jRCTs031180352

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: post cardiac arrest syndrome
• Date of first enrollment: 20/03/2017
• Target sample size: 360
• Study type: Interventional
• Intervention(s): 2%hydrogen+oxygen

Outcome(s)

• Primary Outcome: Rate of favorable neurological outcome (Cerebral Performance Category (CPC) 1 or 2) at 90 days

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Homma Koichiro
• Source(s) of Monetary Support: Taiyo Nippon Sanso Corporation
• Secondary ID(s): UMIN000019820