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.
Tomoyoshi Tamura, Masaru Suzuki, Koichiro Homma, Motoaki Sano · EClinicalMedicine · 2023
Research-use notice
Independent study record
Each H2HUBB study page organizes source-linked research details for educational use. Interpretation should remain proportional to the study design, population, controls, and limitations.
H2HUBB TAKEAWAY
In 429 patients with a 90-day Cerebral Performance Category (CPC) of 1 or 2 assessed in a full-analysis set, the Cox proportional hazards model showed a lower adjusted hazard ratio with H₂ inhalation (0.38; 95% CI, 0.12–1.19; P = 0.09); however, the difference from the control group was not statistically significant ( Table S7 ). The increase in participants with good neurological outcomes following post-OHCA H₂ inhalation in a selected population of patients was not statistically significant. These findings add human evidence supporting molecular hydrogen's therapeutic potential for recovery after myocardial infarction.
What the Findings Mean
H2HUBB reviewed how inhaled hydrogen gas affected the outcomes measured in 429 patients with a 90-day Cerebral Performance Category (CPC) of 1 or 2 assessed in a full-analysis set. The Cox proportional hazards model showed a lower adjusted hazard ratio with H₂ inhalation (0.38; 95% CI, 0.12–1.19; P = 0.09); however, the difference from the control group was not statistically significant ( Table S7 ). The increase in participants with good neurological outcomes following post-OHCA H₂ inhalation in a selected population of patients was not statistically significant.
What the Researchers Studied
The researchers studied 429 patients with a 90-day Cerebral Performance Category (CPC) of 1 or 2 assessed in a full-analysis set. The study used a randomized, double-blind, placebo-controlled human clinical trial. The comparison condition was placebo.
What Effects Did Molecular Hydrogen Have?
Source-reported hydrogen concentration: 2% source-reported H₂ gas concentration; Source-reported hydrogen exposure: 2% source-reported H₂ gas concentration; reported treatment duration: 20 min. The Cox proportional hazards model showed a lower adjusted hazard ratio with H₂ inhalation (0.38; 95% CI, 0.12–1.19; P = 0.09); however, the difference from the control group was not statistically significant ( Table S7 ). The increase in participants with good neurological outcomes following post-OHCA H₂ inhalation in a selected population of patients was not statistically significant. The authors concluded that however, the secondary outcomes suggest that H₂ inhalation may increase 90-day survival without neurological deficits.
Why These Findings Matter
These findings add human evidence supporting molecular hydrogen's therapeutic potential for recovery after myocardial infarction and contribute to the growing body of molecular-hydrogen research.
How Strong Is This Evidence?
This is human clinical evidence from a randomized, double-blind, placebo-controlled human clinical trial. H2HUBB interprets the findings in the context of the study design, sample, comparator, and measured outcomes rather than using one publication as a verdict on hydrogen therapy.
Technical Study Details
H2HUBB classifies this publication as human clinical study with human clinical evidence. The research population or model was 429 patients with a 90-day Cerebral Performance Category (CPC) of 1 or 2 assessed in a full-analysis set. The reported sample size was 429. The study used a randomized, double-blind, placebo-controlled human clinical trial. The hydrogen delivery method was inhaled hydrogen gas. The source-reported hydrogen concentration was 2% source-reported H₂ gas concentration. The reported treatment duration was 20 min.
Limitations and Safety
The small sample size may explain the lack of a significant intergroup difference in the primary outcome. 8, 30 However, the results of this study should be interpreted cautiously due to a small sample size. Safety information: H₂ inhalation is safe and feasible in patients after CA. To ensure safety, the researchers used initial H₂ at a non-flammable concentration of 4% in prefilled gas in cylinders, so the maximum O₂ concentration was limited to 50%, and maximum administration for 18 h.
Original Study and H2HUBB Research Context
H2HUBB presents this source-grounded research record as one contribution to the broader molecular-hydrogen evidence base.