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Hydrogen's Feasibility and Safety as a Therapy in ECPR

NCT05574296 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-07-03

No results posted yet for this study

Summary

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

  • Cardiac Arrest
  • Extracorporeal Membrane Oxygenation
  • Reperfusion Injury

Interventions

DRUG

Hydrogen

Hydrogen gas (2%) in air or oxygen administered for 72 hours via ventilator and ECMO membrane. Oxygen concentration titrated per clinical team.

OTHER

Usual care

Usual care post-ECPR event, including targeted temperature management.

Sponsors & Collaborators

Principal Investigators

  • John N Kheir, MD · Associate Professor of Pediatrics, Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2027-03-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05574296 on ClinicalTrials.gov