HYBRID2 trial

Phase 2

• Conditions: post cardiac arrest syndrome

• Registration Number: JPRN-jRCTs031180352
• Lead Sponsor: Homma Koichiro

Brief Summary

The proportion of 90-day CPC 1 and 2 increased by 17% with H2; however, it did not reach statistical significance. Despite a small number of enrolled patients, H2 gas inhalation significantly increased 90-day survival with mRS of 0 after OHCA.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Study Completion: 2021-09-30
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 73

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified