Hydrogen's Feasibility and Safety as a Therapy in ECPR
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBoston Children's Hospital
About this trial
The purpose of this project is to test the feasibility and safety of inhaled hydrogen gas (H2) administration as a rescue therapy during cardiac arrest requiring extracorporeal cardiopulmonary resuscitation (ECPR, i.e. mechanical circulatory support). Under exemption from informed consent, patients undergoing refractory cardiac arrest in the cardiac ICU at a participating center will be randomized to standard therapy with or without the administration of 2% hydrogen in gases administered via the ventilator and ECMO membrane for 72 hours.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to a cardiac intensive care unit at a participating site with cardiac comorbidity, including congenital heart disease, myocarditis, cardiac arrhythmia, or rejection of a transplanted heart.
Patients are anticipated to be between birth to 18 years of age, although occasionally a patient over the age of 18 may be enrolled.
Patient experiencing a refractory cardiac arrest >5 minutes and receiving ongoing CPR in the ICU, cardiac catheterization lab, or cardiac operating room.
The decision made by the clinical team to resuscitate from ongoing, refractory cardiac arrest using ECPR due to a lack of other available options.
Disqualifiers
Enrollment in the opt-out program.
Patients known to be pregnant.
Patients who are prisoners.
Prior ECPR episode during admission (whether or not they were enrolled in the trial).
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrogen
DrugHydrogen gas (2%) in air or oxygen administered for 72 hours via ventilator and ECMO membrane. Oxygen concentration titrated per clinical team.
Usual care
Other interventionUsual care post-ECPR event, including targeted temperature management.
Treatment groups
53 Participants
are divided into 2 treatment groupsGroup A: Usual care + H2 therapyExperimental treatment 2 interventions
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of hydrogen administration (primary)
Percentage of the first 72 consecutive post-arrest hours (starting at the time of first CPR initiation) in which H2 gas was administered via all of the applicable pathways (e.g. mechanical ventilator and ECMO membrane).
Time frame
72 hours2
Safety of hydrogen administration
Incidence rate of SAEs of interest per day during the first 30 days post-randomization that have been classified as treatment-related or possibly treatment-related.
Time frame
30 daysSecondary outcomes
1
Survival to hospital discharge
Survival to hospital discharge
Time frame
From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months2
ICU length of stay
Duration of ICU stay until first transfer out of ICU
Time frame
From date of randomization until the date of first ICU discharge or date of death from any cause, whichever came first, assessed up to 12 months3
Hospital length of stay
Duration of hospital stay until first hospital discharge
Time frame
From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months4
Functional status score
Functional status score computed based on a detailed review of neurology notes, primary team notes, nursing notes and physical exam documentation by two independent investigators.
Time frame
Calculated on admission to the hospital, at 24 h before cardiac arrest, at hospital discharge, and at 6 months post-randomizationSponsors and contacts
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Source ClinicalTrials.gov