Recruiting
Phase 2

Inhaled Nitric Oxide

Sponsor:

The Hospital for Sick Children

Code:

NCT05868109

Conditions

Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

inhaled nitric oxide (iNO)

Sham

Study Details

Brief 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).

Conditions

Cardiac Arrest

Study ID

NCT05868109

Start date

Aug 31, 2022

Status verified date

Nov, 2023

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

inhaled nitric oxide (iNO)

In patients randomized to the this arm, iNO will be delivered into the ventilator circuit through the endotracheal tube or tracheostomy. The dose will be 80 ppm during chest compressions and reduced to 20 ppm immediately following ROC. If the patient is enrolled following ROC, the dose will be 20 ppm. Dose modifications will occur if there is toxicity or if there is a clinical concern. The iNO or sham will be continued for 72 hours or until extubation.

Sham

In patients randomized to sham, the iNO delivery device will be connected to the ventilator circuit or manual ventilation bag but flow of iNO will not be turned on. For the purposes of patient safety and to maintain blinding, the respiratory therapists (RTs) will continue checks of gas flow, flow adjustments and change iNO gas tanks at rates like routine clinical procedures on patients treated with iNO or sham.

Primary outcome measure

  • Drug Procedural Feasibility [ Time Frame: We will monitor screening numbers, rates of enrolment of eligible patients and delivery of study intervention according to CONSORT criteria over the 2 year timeframe of study enrolment. ]
  • Drug Procedural Feasibility [ Time Frame: We will monitor compliance to the study intervention during the 72 hours of drug/sham delivery and 12 hours of weaning and stopping the study intervention on each enrolled patient over the 2 years of study enrolment. ]

Central Contacts and Locations

Central contacts

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Nov 30, 2023

Last verified

Nov, 2023

Keywords

  • Neuroprotection
  • Nitric Oxide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2023-11-30.