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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 80
Healthy Volunteers: f
View:

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

• Aged 1 day\* to 80 years on the day the study intervention is started

• In-hospital or out-of-hospital CA with CPR \> 5 minutes

• It is possible to randomize and start the iNO or sham during CPR or within 5 hours of ROC\*\*

• 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).

Locations
Other Locations
Canada
St. Michael's Hospital
NOT_YET_RECRUITING
Toronto
The Hospital for Sick Children
RECRUITING
Toronto
Toronto General Hospital
RECRUITING
Toronto
Toronto Western Hospital
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Jamie Hutchison, MD
jamie.hutchison@sickkids.ca
416-915-1857
Backup
John Granton, MD
john.granton@uhn.on.ca
647-225-4485
Time Frame
Start Date: 2022-08-31
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 40
Treatments
Sham_comparator: Participants with Sham (no nitric oxide)
The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device but nitric oxide is not delivered.
Experimental: Participants with Nitric Oxide
The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device and nitric oxide is delivered.
Related Therapeutic Areas
Sponsors
Leads: The Hospital for Sick Children
Collaborators: Heart and Stroke Foundation of Canada

This content was sourced from clinicaltrials.gov