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Usual care + H2 therapy for Reperfusion Injury (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

HydrogenFAST Trial 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.Check my eligibility

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.See study design

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.

HydrogenFAST Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of hydrogen administration

Hydrogen

Secondary outcome measures

Functional status score

Hospital length of stay

ICU length of stay

+1 more

HydrogenFAST Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Usual care + H2 therapyExperimental Treatment2 Interventions

Hydrogen administered via mechanical ventilator and sweep gas into ECMO membrane for 72 hours

Group II: Usual careActive Control1 Intervention

The current standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydrogen

2018

Completed Phase 3

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,677 Total Patients Enrolled

1 Trials studying Reperfusion Injury

242 Patients Enrolled for Reperfusion Injury

Baylor College of MedicineOTHER

1,001 Previous Clinical Trials

6,002,159 Total Patients Enrolled

John N Kheir, MDPrincipal InvestigatorAssociate Professor of Pediatrics, Harvard Medical School

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals who are being enrolled in this medical study?

"Yes, the details on clinicaltrials.gov reveal that this research is actively seeking participants. The trial was first listed on March 4th, 2024 and most recently revised on March 8th, 2024. They aim to recruit a total of 53 subjects from one designated site."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"Indeed, information on clinicaltrials.gov confirms that this investigation is actively seeking candidates. Originally shared on March 4th, 2024, the content was most recently revised on March 8th of the same year. The study aims to enlist a total of 53 participants from one designated site."

Answered by AI

What are the main goals being pursued in this research endeavor?

"This research aims to evaluate the safety of hydrogen administration within a period of approximately 72 hours. Secondary measures encompass Functional status score, defined as an assessment derived from a comprehensive analysis of neurology records, primary team reports, nursing documentation and physical exam results by two impartial evaluators; Survival until hospital discharge meaning successful survival until hospital discharge post-treatment; and ICU length of stay indicating the duration spent in intensive care unit before initial transfer out."

Answered by AI

What are the safety considerations for individuals receiving standard care in addition to H2 therapy?

"Based on our team's evaluation at Power, the safety rating for Usual care + H2 therapy is a 1 as this trial falls under Phase 1 with scarce evidence supporting both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hydrogen's Feasibility and Safety as a Therapy in ECPR

John Kheir 2024. "Hydrogen's Feasibility and Safety as a Therapy in ECPR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05574296.

All > Ecmo