Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA)

• Status: Recruiting
• Trial end date: 2026-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multi-center, double blind, randomized controlled trial of inhaled nitric oxide (iNO) in children and adults with cardiac arrest (CA). The purpose of this pilot study is to test the feasibility of rapidly randomizing patients to iNO or sham treatment during cardiopulmonary resuscitation (CPR) or shortly after return of circulation (ROC) and evaluate blood biomarkers associated with iNO compared to sham. Return of circulation may refer to return of spontaneous circulation (ROSC) or ROC through extracorporeal cardiopulmonary resuscitation (E-CPR).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Heart and Stroke Foundation of Canada
• Treatments: Nitric Oxide

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**

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