Actively Recruiting

Phase 1
All Genders
NCT05574296

Hydrogen's Feasibility and Safety as a Therapy in ECPR

Led by Boston Children's Hospital · Updated on 2025-07-03

53

Participants Needed

4

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hydrogen's Feasibility and Safety as a Therapy in ECPR

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to a cardiac intensive care unit with cardiac conditions such as congenital heart disease, myocarditis, arrhythmia, or transplanted heart rejection
  • Patients anticipated to be from birth to 18 years old, with occasional enrollment of patients over 18
  • Patients experiencing refractory cardiac arrest lasting more than 5 minutes and receiving ongoing CPR in ICU, catheterization lab, or operating room
  • Clinical decision to resuscitate using extracorporeal cardiopulmonary resuscitation (ECPR) due to lack of other options
Not Eligible

You will not qualify if you...

  • Enrollment in the opt-out program
  • Known pregnancy
  • Prisoner status
  • Prior ECPR episode during the same admission
  • Enrollment not occurring within 6 hours of the decision to use ECPR
  • ECMO cannulation without preceding CPR (does not qualify as ECPR)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Children's National Hospital

Washington D.C., District of Columbia, United States, 20010

Not Yet Recruiting

2

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

3

Children's Mercy Kansas City

Kansas City, Missouri, United States, 64108

Not Yet Recruiting

4

Primary Children's Hospital

Salt Lake City, Utah, United States, 84132

Not Yet Recruiting

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Research Team

J

John N Kheir, MD

CONTACT

V

Victoria Habet, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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