HYBRID II
Trial question
What is the role of inhaled hydrogen gas in patients with coma following cardiogenic out-of-hospital cardiac arrest?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 73
73 patients (14 female, 59 male).
Inclusion criteria: patients aged 20-80 years with coma following cardiogenic out-of-hospital cardiac arrest.
Key exclusion criteria: known pre-arrest cerebral performance category score of 3 or 4; known treatment limitations; DNR order; trauma-associated out-of-hospital cardiac arrest; oxygen saturation < 94% with 50% oxygen inhalation.
Interventions
N=39 hydrogen gas (inhalation of 2% hydrogen gas for 18 hours).
N=34 control (inhalation of titrated oxygen gas for 18 hours).
Primary outcome
Cerebral performance category of 1 or 2 at day 90
56%
39%
56.0 %
42.0 %
28.0 %
14.0 %
0.0 %
Hydrogen
gas
Control
No significant
difference ↔
No significant difference in cerebral performance category of 1 or 2 at day 90 (56% vs. 39%; RR 0.72, 95% CI 0.46 to 1.13).
Secondary outcomes
Significant decrease in median mRS score at day 90 (1 points vs. 5 points; AD -4 points, 95% CI -7.04 to -0.96).
Significant increase in survival at day 90 (85% vs. 61%; RR 2.5, 95% CI 1.09 to 5.88).
Significant increase in mRS score of 0 (46% vs. 21%; RR 2.18, 95% CI 1.04 to 4.56).
Safety outcomes
No significant difference in adverse events and serious adverse events.
Conclusion
In patients aged 20-80 years with coma following cardiogenic out-of-hospital cardiac arrest, hydrogen gas was not superior to control with respect to cerebral performance category of 1 or 2 at day 90.
Reference
Tomoyoshi Tamura, Masaru Suzuki, Koichiro Homma et al. Efficacy of inhaled hydrogen on neurological outcome following brain ischaemia during post-cardiac arrest care (HYBRID II): a multi-centre, randomised, double-blind, placebo-controlled trial. EClinicalMedicine. 2023 Mar 17;58:101907.
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