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

Tomoyoshi Tamura, Kei Hayashida, Motoaki Sano, Shuko Onuki, Masaru Suzuki

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish
Article number488
JournalTrials
Volume18
Issue number1
DOIs
Publication statusPublished - 2017 Oct 23

Fingerprint

Clinical Protocols
Heart Arrest
Brain Ischemia
Hydrogen
Randomized Controlled Trials
Inhalation
Gases
Out-of-Hospital Cardiac Arrest
Coma
Oxygen
Control Groups
Glasgow Coma Scale
Temperature
Information Services
Artificial Respiration
Multicenter Studies
Survivors
Survival Rate
Animal Models
Placebos

Keywords

  • Hydrogen gas inhalation
  • Out-of-hospital cardiac arrest
  • Post-cardiac arrest syndrome

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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. / Tamura, Tomoyoshi; Hayashida, Kei; Sano, Motoaki; Onuki, Shuko; Suzuki, Masaru.

In: Trials, Vol. 18, No. 1, 488, 23.10.2017.

Research output: Contribution to journalArticle

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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.",
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