Abstract 14562: First-in-human Pilot Study of Hydrogen Gas Inhalation for Treatment of Post-cardiac Arrest Syndrome
Background: Recent proof-of-concept studies in animal models have demonstrated a therapeutic effect of H2 Inhalation (HI) on neurological outcomes following cardiac arrest (CA). In this study, we sought to evaluate the feasibility and safety of HI during patient post-CA care.
Methods: The study was an open-label, single-arm, prospective intervention trial. We consecutively enrolled 5 patients (3 males, age 65 ± 15 years) between January 1, 2014, and January 19, 2015. Collapse was observed in all patients, 4 patients received bystander-performed cardiopulmonary resuscitation, 4 patients were initially in ventricular fibrillation, and 4 patients had a CA of cardiac cause. 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 target temperature management (TTM) between 33°C and 36°C. HI (2% H2 with oxygen) was initiated through a ventilator upon ICU admission and was continued for 18 h. During HI, patients were ventilated using volume-controlled, continuous, mandatory ventilation. The actual respiratory conditions, tidal volume, FiO2, end-tidal CO2, and H2 concentration were continuously monitored by additionally installed monitoring devices. Blood H2 concentration was measured by gas chromatography during HI. Adverse event (AE) was recorded during the first week of admission. The data and safety monitoring committee examined the causal relationship of AEs and HI and judged the safety of HI. The neurologically intact survival rates [i.e., patients with a cerebral performance category (CPC) of 1–2] were assessed 90 days after CA.
Results: H2 in inspiratory gas and blood was both confirmed as 2 % during HI. HI did not interfere with post-cardiac arrest syndrome (PCAS) care, including TTM. An outcome of CPC 1 was achieved by 4 out of 5 patients. One CA patient with severe pneumonia and septic shock died because of respiratory deterioration 22 hours after the completion of HI. Although most adverse events were of a potentially serious nature, they were often common in PCAS patients, with or without HI. No adverse effects related to HI were observed.
Conclusion: HI is a safe and feasible procedure for patients with PCAS.
Author Disclosures: T. Tamura: None. K. Hayashida: None. M. Suzuki: None. M. Sano: Research Grant; Significant; Taiyo Nippon Sanso corporation. J. Yoshizawa: None. T. Shibusawa: None. Y. Kobayashi: None. T. Suzuki: None. S. Ohta: None. H. Morisaki: None. K. Fukuda: None. S. Hori: None.
- © 2016 by American Heart Association, Inc.