Using inhaled nitric oxide for cardiac arrest treatment in children and adults

Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA): A Pilot Randomized Controlled Trial and Translational Biology Study

This study is testing if inhaled nitric oxide can help improve recovery for children and adults who have had a cardiac arrest during CPR.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 1 Day to 80 Years
• Sex: All
• Sponsor: The Hospital for Sick Children (Academic / other)
• Locations: 4 sites (Toronto, Ontario and 3 other locations)
• Trial ID: NCT05868109 on ClinicalTrials.gov

What this trial studies

This pilot study is a multi-center, double-blind, randomized controlled trial evaluating the feasibility and safety of inhaled nitric oxide (iNO) in patients experiencing cardiac arrest. Participants, aged from 1 day to 80 years, will be randomly assigned to receive either iNO or a sham treatment during cardiopulmonary resuscitation (CPR) or shortly after return of circulation. The study aims to assess blood biomarkers associated with iNO treatment compared to sham, with outcomes measured for six months post-arrest. This research could pave the way for larger trials and improve neuroprotective strategies in cardiac arrest management.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 1 day to 80 years who have experienced in-hospital or out-of-hospital cardiac arrest with CPR lasting more than 5 minutes.

Not a fit: Patients who have experienced unwitnessed cardiac arrest or have pre-existing poor neurological function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and neurological outcomes for patients who experience cardiac arrest.

How similar studies have performed: Other studies have shown promising results with inhaled nitric oxide in animal models, but this approach is still being tested in human subjects.

Eligibility criteria

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria:

1. Aged 1 day\* to 80 years on the day the study intervention is started
2. In-hospital or out-of-hospital CA with CPR \> 5 minutes
3. It is possible to randomize and start the iNO or sham during CPR or within 5 hours of ROC\*\*
4. Mechanically ventilated in a study site ICU

Note: \*Age 1 day is defined as 24 hours and a minimum corrected gestational age ≥ 38 weeks.

Note: \*\*ROC refers to either ROSC or ROC via extracorporeal cardiopulmonary resuscitation (E-CPR).

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unwitnessed cardiac arrest
2. Cardiac arrest due to birth asphyxia
3. Pre-arrest poor neurologic function\*
4. Already receiving iNO at the time of CA
5. Any condition or diagnosis, in the opinion of the PI, Co-Investigators, or MRPs, in which iNO would have adverse effects on physiology or where the cardiac anatomy and physiology has not yet been adequately assessed
6. Any condition or diagnosis, in the opinion of the PI, Co-Investigators, or MRPs, in which iNO would be indicated as therapy post-arrest
7. CPR duration \> 45 minutes; if less than 18 years old, in-hospital CPR duration \> 60 minutes\*\*
8. Known pregnancy\*\*\*
9. Terminal illness ʈ

Note: \* Poor neurologic function is defined as CPC ≥ 4 or PCPC ≥ 4.

Note: \*\*CPR duration is defined as total cumulative duration of CPR (i.e., if a patient has multiple arrests with CPR, the duration of these will be added); patients who undergo E-CPR will not be excluded, to maximize recruitment for this feasibility trial.

Note: \*\*\*B-HCG screening is not required for enrollment in women of reproductive age, but testing will occur as soon as possible (within 6 hours of enrollment).

Patients who are cannulated to ECMO for cardiorespiratory support will NOT be excluded a priori.

ʈ The MRP knew that the patient was dying pre-arrest

Where this trial is running

Toronto, Ontario and 3 other locations

• St. Michael's Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
• Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
• Toronto Western Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
• The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Jamie Hutchison, MD — The Hospital for Sick Children
• Study coordinator: Jamie Hutchison, MD

Conditions Cardiac Arrest; Neuroprotection; Nitric Oxide