Format

Send to

Choose Destination

See 1 citation found by title matching your search:

Trials. 2017 Oct 23;18(1):488. doi: 10.1186/s13063-017-2246-3.

Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II trial): study protocol for a randomized controlled trial.

Author information

1
Department of Emergency and Critical Care Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinkuku-ku, Tokyo, 160-8582, Japan. tamura8@keio.jp.
2
The Center for Molecular Hydrogen Medicine, Keio University, 2-15-45 Mita, Minato-ku, Tokyo, 108-8345, Japan. tamura8@keio.jp.
3
Department of Emergency and Critical Care Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinkuku-ku, Tokyo, 160-8582, Japan.
4
The Center for Molecular Hydrogen Medicine, Keio University, 2-15-45 Mita, Minato-ku, Tokyo, 108-8345, Japan.
5
Department of Cardiology, Keio University School of Medicine, 35 Shinanomachi, Shinkuku-ku, Tokyo, 160-8582, Japan.

Abstract

BACKGROUND:

Hydrogen gas inhalation (HI) improved survival and neurological outcomes in an animal model of post-cardiac arrest syndrome (PCAS). The feasibility and safety of HI for patients with PCAS was confirmed in a pilot study. The objective of this study is to evaluate the efficacy of HI for patients with PCAS.

METHODS/DESIGN:

The efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II) trial is an investigator-initiated, randomized, double-blind, placebo-controlled trial designed to enroll 360 adult comatose (Glasgow Coma Scale score < 8) patients who will be resuscitated following an out-of-hospital cardiac arrest of a presumed cardiac cause. The patients will be randomized (1:1) to either the HI or control group. Patients in the HI group will inhale 2% hydrogen with 24% to 50% oxygen, and those in the control group will inhale 24% to 50% oxygen for 18 h after admission via mechanical ventilation. Multidisciplinary post-arrest care, including targeted temperature management (TTM) between 33 °C and 36 °C, will be provided in accordance with the latest guidelines. The primary outcome of interest is the 90-day neurological outcome, as evaluated using the Cerebral Performance Categories scale (CPC). The secondary outcomes of interest are the 90-day survival rate and other neurological outcomes. This study will provide 80% power to detect a 15% change in the proportion of patients with good neurological outcomes (CPCs of 1 and 2), from 50% to 65%, with an overall significance level of 0.05.

DISCUSSION:

The first multicenter randomized trial is underway to confirm the efficacy of HI on neurological outcomes in comatose out-of-hospital cardiac arrest survivors. Our study has the potential to address HI as an appealing and innovative therapeutic strategy for PCAS in combination with TTM.

TRIALS REGISTRATION:

University Hospital Medical Information Network (UMIN), 000019820 . Registered on 17 November 2015.

KEYWORDS:

Out-of-hospital cardiac arrest; hydrogen gas inhalation; post-cardiac arrest syndrome

PMID:
29058596
PMCID:
PMC5651618
DOI:
10.1186/s13063-017-2246-3
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center