Cardiac ArrestPhase 2iNOCAPANCT05868109
Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA)
A Phase 2 study testing inhaled nitric oxide (iNO) in people with Cardiac Arrest, run by The Hospital for Sick Children at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 80 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- inhaled nitric oxide (iNO)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesCanada
- Study dates
- 31 Aug 2022to 31 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unwitnessed cardiac arrest
- Cardiac arrest due to birth asphyxia
- Pre-arrest poor neurologic function*
- Already receiving iNO at the time of CA
- 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
Show all 15Show fewer
- Any condition or diagnosis, in the opinion of the PI, Co-Investigators, or MRPs, in which iNO would be indicated as therapy post-arrest
- CPR duration > 45 minutes; if less than 18 years old, in-hospital CPR duration > 60 minutes**
- Known pregnancy***
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Andrew Baker, MD, (416) 864-5559, Andrew.Baker@unityhealth.to
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G2C4
John Granton, MD, 416-340-4485, john.granton@uhn.ca
- Not yet recruiting
Toronto Western Hospital
Toronto, Ontario, M5T2S8
Victoria McCredie, MD, victoria.mccredie@uhn.ca
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
Jamie Hutchison, MD, 416-813-7654 ext. 304549, jamie.hutchison@sickkids.ca
About this study
Official title: Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA): A Pilot Randomized Controlled Trial and Translational Biology Study
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).
Read the detailed description
Background: Sudden cardiac arrest is a leading cause of death and neurological handicaps but there is no neuroprotective drug which improves outcome. Recently we discovered a blood biomarker of response to a neuroprotective therapy in our pre-clinical model of cerebral ischemia-reperfusion injury. Biomarkers will likely be used, in the future, to assess response to specific neuroprotective drugs and to help titrate drug dose and duration in individual patients.
Inhaled nitric oxide (iNO) has recently been shown to improve return of spontaneous circulation, survival, and neurological outcome in animal models of cardiac arrest. We have therefore started a pilot randomized controlled trial (RCT) and translational biology study of iNO in children and adults with cardiac arrest. This study will help us design future fully powered RCTs of iNO. We will use methods, from our pre-clinical model, to discover blood biomarkers of response to therapy.
Objectives: In patients with cardiac arrest: (1) Test the safety and feasibility of rapidly randomizing patients to iNO or sham during chest compressions, or shortly after return of circulation (ROC), either spontaneous or by extracorporeal life support. (2) Maintain blinding and measure study outcomes for 6 months post-arrest. (3) Use immunoassays, mass spectrometry and fluorometric assays to determine the differences in serum protein, nitrite, and nitrate biomarker concentrations between the two intervention groups and discover blood biomarkers of therapeutic response to iNO.
Patient population and sample size: Pediatric and adult (total N=40) patients with cardiac arrest admitted to 8 intensive care units (ICUs) at 4 hospitals: SickKids, University Health Network - Toronto General Hospital (TGH) and Toronto Western Hospital (TWH) and Unity Health - St. Michael's Hospital (SMH).
Methods: All patients meeting eligibility criteria will be enrolled, during chest compressions or within 6 hours of ROC, using deferred consent. Patients will be randomized to iNO or sham procedures, using a Redcap screening and randomization tool. Registered respiratory therapists will rapidly start the study gas using our blinded study apparatus. Inhaled NO will be started at a dose of 80 ppm via the endotracheal or tracheostomy tube during chest compressions and reduced to, or started at, 20 ppm after ROC. The iNO or sham procedures will be continued for 72 hours, and weaned off over 12 hours, or stopped earlier if the patient is extubated or dies. Using the Utstein data template for cardiac arrest research, we will collect data into an electronic case report form and Oracle database. Survival, cerebral performance category scores and quality of life scores will be assessed at 1 and 6 months following cardiac arrest. Data and documentation will be reviewed intermittently to ensure that we are compliant with Health Canada guidelines for drug trials.
Serum is being collected and banked at 4 time points following cardiac arrest. The concentrations of biomarkers will be measured and compared between the 2 intervention groups.
Progress: This study is funded by the Heart and Stroke Foundation of Canada.
- Conditions
- Cardiac Arrest
- Being tested
- inhaled nitric oxide (iNO), Sham
- Keywords
- Neuroprotection, Nitric Oxide
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled nitric oxide (iNO)Drug
Also called INOMAX
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.
ShamDrug
Also called Sham intervention with no flow of inhaled nitric oxide to the patient
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Sham (no nitric oxide) | Sham comparator | The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device but nitric oxide is not delivered. Receives: Drug: Sham |
| Participants with Nitric Oxide | Experimental | The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device and nitric oxide is delivered. Receives: Drug: inhaled nitric oxide (iNO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Procedural Feasibility
Number of successful initiations of iNO or sham among the 40 patients enrolled in the study. We will monitor and improve our rates of enrolment and study intervention by examining and improving upon factors related to protocol compliance.
Measured: 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
Number of successful continuations of iNO or sham for 72 hours followed by weaning and stopping the study intervention over the next 12 hours. Using real time monitoring of the study intervention we will optimize compliance to the full duration of the study intervention and improve upon any deviations to the study intervention over the full 72 + 12 hours of the study protocol.
Measured: 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.
Secondary outcomes (4)
Monitor recruitment rate
Recruitment rate is the rate of enrolment/randomization/consent divided by the number of eligible patients which meet all inclusion criteria and have no exclusion criteria.
Measured: For study duration, approximately 2 years.
Monitor time to randomization of eligible patients
Timing of randomization. The time of randomization following onset of cardiac arrest will be recorded. We will attempt to speed up this time using simulations with study and clinical personnel and by debriefing each enrolled patient with the teams involved. We will attempt to enrol some patients who have a cardiac arrest in the ICU during chest compressions and for those patients enrolled following return of circulation, the timeframe is a maximum of 5 hours.
Measured: At study enrollment during the 2 years of study recruitment.
Monitor masking and unmasking events
Number of unblinding instances. The study apparatus (inhaled nitric oxide gas delivery device) has a secure cover that only the Respiratory Therapists are trained to open. The RTs will record any unblinding events which may include breaking/cutting of the cover ties and opening of the apparatus cover by clinical personnel other than RTs. The RTs will record and sign 'unblinding yes/no' into their masked RT study case report form on each RT clinical shift and study Research Coordinators will enter this data into the study electronic database. We will monitor unblinding events in real time and attempt to prevent these from happening.
Measured: During the 2 year study duration and data analysis.
Study follow-up rates
We will measure outcomes at 1 and 6 months following cardiac arrest as outlined in more detail below. Number of completed study outcomes at 6 months following cardiac arrest will be followed in real time and we will attempt to maximize follow-up rates.
Measured: For study follow-up, approximately 2.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start31 Aug 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Jamie Hutchison, The Hospital for Sick Children
- Investigators
- Jamie Hutchison, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868109
- Sponsor's protocol ID
- 1822
- Acronym
- iNOCAPA
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data (IPD) that underlie results in a publication will be shared upon request. The study protocol, and statistical analysis plan will be shared starting 6 months after publication upon request in writing. Requests for IPD will be reviewed by the study PI and SickKids institute. IPD will be provided to researchers interested in furthering academia and research development only. IPD requests may also be subjected to SickKids' institutional agreements/contracts. IPD mechanism of sharing and types of analysis/data shared will be directed and determined by SickKids' institutional research contracts requirements
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA): A Pilot Randomized Controlled Trial and Translational Biology Study
- ClinicalTrials.gov ID
- NCT05868109
- Acronym / sponsor ID
- iNOCAPA / 1822
- Conditions
- Cardiac Arrest
- Keywords
- Neuroprotection, Nitric Oxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background: Sudden cardiac arrest is a leading cause of death and neurological handicaps but there is no neuroprotective drug which improves outcome. Recently we discovered a blood biomarker of response to a neuroprotective therapy in our pre-clinical model of cerebral ischemia-reperfusion injury. Biomarkers will likely be used, in the future, to assess response to specific neuroprotective drugs and to help titrate drug dose and duration in individual patients.
Inhaled nitric oxide (iNO) has recently been shown to improve return of spontaneous circulation, survival, and neurological outcome in animal models of cardiac arrest. We have therefore started a pilot randomized controlled trial (RCT) and translational biology study of iNO in children and adults with cardiac arrest. This study will help us design future fully powered RCTs of iNO. We will use methods, from our pre-clinical model, to discover blood biomarkers of response to therapy.
Objectives: In patients with cardiac arrest: (1) Test the safety and feasibility of rapidly randomizing patients to iNO or sham during chest compressions, or shortly after return of circulation (ROC), either spontaneous or by extracorporeal life support. (2) Maintain blinding and measure study outcomes for 6 months post-arrest. (3) Use immunoassays, mass spectrometry and fluorometric assays to determine the differences in serum protein, nitrite, and nitrate biomarker concentrations between the two intervention groups and discover blood biomarkers of therapeutic response to iNO.
Patient population and sample size: Pediatric and adult (total N=40) patients with cardiac arrest admitted to 8 intensive care units (ICUs) at 4 hospitals: SickKids, University Health Network - Toronto General Hospital (TGH) and Toronto Western Hospital (TWH) and Unity Health - St. Michael's Hospital (SMH).
Methods: All patients meeting eligibility criteria will be enrolled, during chest compressions or within 6 hours of ROC, using deferred consent. Patients will be randomized to iNO or sham procedures, using a Redcap screening and randomization tool. Registered respiratory therapists will rapidly start the study gas using our blinded study apparatus. Inhaled NO will be started at a dose of 80 ppm via the endotracheal or tracheostomy tube during chest compressions and reduced to, or started at, 20 ppm after ROC. The iNO or sham procedures will be continued for 72 hours, and weaned off over 12 hours, or stopped earlier if the patient is extubated or dies. Using the Utstein data template for cardiac arrest research, we will collect data into an electronic case report form and Oracle database. Survival, cerebral performance category scores and quality of life scores will be assessed at 1 and 6 months following cardiac arrest. Data and documentation will be reviewed intermittently to ensure that we are compliant with Health Canada guidelines for drug trials.
Serum is being collected and banked at 4 time points following cardiac arrest. The concentrations of biomarkers will be measured and compared between the 2 intervention groups.
Progress: This study is funded by the Heart and Stroke Foundation of Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Participants with Sham (no nitric oxide) | Sham comparator | Drug: ShamThe mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device but nitric oxide is not delivered. |
| Participants with Nitric Oxide | Experimental | Drug: inhaled nitric oxide (iNO)The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device and nitric oxide is delivered. |
Who may qualify
- Ages
- 1 day to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unwitnessed cardiac arrest
- Cardiac arrest due to birth asphyxia
- Pre-arrest poor neurologic function*
- Already receiving iNO at the time of CA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled nitric oxide (iNO)Also: INOMAXIn 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. | Drug | Participants with Nitric Oxide |
| ShamAlso: Sham intervention with no flow of inhaled nitric oxide to the patientIn 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. | Drug | Participants with Sham (no nitric oxide) |
Primary outcome
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.
Number of successful initiations of iNO or sham among the 40 patients enrolled in the study. We will monitor and improve our rates of enrolment and study intervention by examining and improving upon factors related to protocol compliance.
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.
Number of successful continuations of iNO or sham for 72 hours followed by weaning and stopping the study intervention over the next 12 hours. Using real time monitoring of the study intervention we will optimize compliance to the full duration of the study intervention and improve upon any deviations to the study intervention over the full 72 + 12 hours of the study protocol.
4 secondary outcomes
Monitor recruitment rate
Time frame: For study duration, approximately 2 years.
Monitor time to randomization of eligible patients
Time frame: At study enrollment during the 2 years of study recruitment.
Monitor masking and unmasking events
Time frame: During the 2 year study duration and data analysis.
Study follow-up rates
Time frame: For study follow-up, approximately 2.5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data (IPD) that underlie results in a publication will be shared upon request. The study protocol, and statistical analysis plan will be shared starting 6 months after publication upon request in writing. Requests for IPD will be reviewed by the study PI and SickKids institute. IPD will be provided to researchers interested in furthering academia and research development only. IPD requests may also be subjected to SickKids' institutional agreements/contracts. IPD mechanism of sharing and types of analysis/data shared will be directed and determined by SickKids' institutional research contracts requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Hutchison, MD principal investigator
The Hospital for Sick Children
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inhaled nitric oxide (iNO) in people with Cardiac Arrest, run by The Hospital for Sick Children at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Hutchison, MD (416-915-1857, jamie.hutchison@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.