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Hydrogen Therapy for Cardiac Arrest (HydrogenFAST Trial)

Phase 1

Recruiting

Led By John N Kheir, MD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up calculated on admission to the hospital, at 24 h before cardiac arrest, at hospital discharge, and at 6 months post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if inhaling hydrogen gas during cardiac arrest and receiving mechanical circulatory support is safe and possible. Patients in the cardiac ICU will either receive standard care or standard care plus inhaling

Who is the study for?

This trial is for patients from birth to 18 years, and occasionally older, who are experiencing a tough-to-treat cardiac arrest and are being treated with ECPR in the ICU at Boston Children's or Texas Children's Hospital. They may have heart conditions like congenital disease, myocarditis, arrhythmia, or transplant rejection.

What is being tested?

The study tests if breathing hydrogen gas is safe and doable as an extra treatment during ECPR for cardiac arrest. Patients will either get standard care or standard plus hydrogen gas through their ventilator and ECMO system for three days.

What are the potential side effects?

Since this trial aims to establish safety, potential side effects of inhaling hydrogen aren't fully known but could include respiratory changes. Usual care side effects depend on individual treatments received alongside ECPR.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ calculated on admission to the hospital, at 24 h before cardiac arrest, at hospital discharge, and at 6 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~calculated on admission to the hospital, at 24 h before cardiac arrest, at hospital discharge, and at 6 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and calculated on admission to the hospital, at 24 h before cardiac arrest, at hospital discharge, and at 6 months post-randomization for reporting.