Out-Of-Hospital Cardiac ArrestPhase 2/3SNOCATNCT03452917
Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
A Phase 2/3 study testing sodium nitrite 45 mg and sodium nitrite 60 mg in people with Out-Of-Hospital Cardiac Arrest, run by University of Washington at 1 site in United States.
Trial summary
In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- sodium nitrite 45 mg and sodium nitrite 60 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,502 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 30 Apr 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac arrest, either VF or non-VF, patients receiving ACLS by paramedics
- IV or IO access
- Comatose
Who cannot join
- traumatic cause of cardiac arrest
- prisoner, pregnancy
- known DNAR
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. The primary outcome will be proportion of patients surviving to hospital admission.
Read the detailed description
The hemodynamic effects of the optimal dose of IV nitrite administered in patients with cardiac arrest are unknown. A significant negative hemodynamic effect from nitrite would decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or increase the need for vasopressor support in the field. In Seattle/King County, typically 40% of out-of-hospital cardiac arrest patients attended to by paramedics have Return of spontaneous circulation (ROSC) and are admitted to the hospital. In this study, 1500 patients with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be randomized to receive placebo (n=500) or 45 mg IV (n=500) or 60 mg dose (n=500) of sodium nitrite. The study will have 80% power to detect an absolute increase in hospital admission rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60 mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40% in the placebo group and with one interim analysis and stopping only for potential futility and/or harm). The investigators will examine the proportion of patients who survive to discharge as a secondary measure of efficacy.
Patients will be eligible for this study if:
- Intravenous access (IV)/intraosseous access(IO)
- Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving Advanced Cardiac Life Support (ACLS) by Seattle/King County paramedics.
- Age 18 years or older
- Comatose
Exclusion Criteria
- Traumatic cause of cardiac arrest
- Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
- Known DNAR
- Drowning as cause of arrest.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Placebo, sodium nitrite 45 mg, sodium nitrite 60 mg
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
500 patients will 2 ml of normal saline
sodium nitrite 45 mgDrug
500 patients will receive 45 mg IV sodium nitrite
sodium nitrite 60 mgDrug
500 patients will receive a dose of 60 mg IV sodium nitrite
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 ml of normal saline (n=500) Receives: Drug: Placebo |
| sodium nitrite | Experimental | 45 mg IV of sodium nitrite (n=500) or 60 mg IV sodium nitrite (n=500) given during active resuscitation from out of hospital cardiac arrest. Receives: Drug: sodium nitrite 45 mg; Drug: sodium nitrite 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Survived to Hospital Admission
Patient has sustained pulse at arrival to the emergency department
Measured: within 24 hours after out of hospital cardiac arrest
Secondary outcomes (6)
Survival to Discharge
Patient alive at time of discharge from hospital
Measured: within 3-6 months after cardiac arrest
Number of Days in ICU
Number of days the patient is admitted to the Intensive Care Unit
Measured: Within first 3 months of hospital admission
Survival to 24 Hours
Patient is alive after the first 24 hours after admission to the hospital
Measured: within first 24 h after hospital admission
Re-arrest
Patient loses pulses during transport to the hospital. Event occurs before admission to hospital.
Measured: before hospital arrival
Survival to 48 Hours After Admission to Hospital
Patient is alive after first 48 hours after admission to the hospital
Measured: within first 48 hours after admission to hospital
Survival to 72 Hours After Admission to Hospital
Patient is alive after first 72 hours after admission to the hospital
Measured: within first 72 hours after admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start8 Feb 2018
- Primary completion31 Dec 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Francis Kim, University of Washington
- Investigators
- Francis Kim, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452917
- Sponsor's protocol ID
- 51605
- Other IDs
- R01HL129722
- Acronym
- SNOCAT
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2018
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim F, Maynard C, Dezfulian C, Sayre M, Kudenchuk P, Rea T, Sampson D, Olsufka M, May S, Nichol G. Effect of Out-of-Hospital Sodium Nitrite on Survival to Hospital Admission After Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Jan 12;325(2):138-145. doi: 10.1001/jama.2020.24326.
PubMed 33433575
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03452917
- Acronym / sponsor ID
- SNOCAT / 51605
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Posted 24 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. The primary outcome will be proportion of patients surviving to hospital admission.
Detailed description
The hemodynamic effects of the optimal dose of IV nitrite administered in patients with cardiac arrest are unknown. A significant negative hemodynamic effect from nitrite would decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or increase the need for vasopressor support in the field. In Seattle/King County, typically 40% of out-of-hospital cardiac arrest patients attended to by paramedics have Return of spontaneous circulation (ROSC) and are admitted to the hospital. In this study, 1500 patients with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be randomized to receive placebo (n=500) or 45 mg IV (n=500) or 60 mg dose (n=500) of sodium nitrite. The study will have 80% power to detect an absolute increase in hospital admission rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60 mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40% in the placebo group and with one interim analysis and stopping only for potential futility and/or harm). The investigators will examine the proportion of patients who survive to discharge as a secondary measure of efficacy.
Patients will be eligible for this study if:
- Intravenous access (IV)/intraosseous access(IO)
- Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving Advanced Cardiac Life Support (ACLS) by Seattle/King County paramedics.
- Age 18 years or older
- Comatose
Exclusion Criteria
- Traumatic cause of cardiac arrest
- Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
- Known DNAR
- Drowning as cause of arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 ml of normal saline (n=500) |
| sodium nitrite | Experimental | Drug: sodium nitrite 45 mg, Drug: sodium nitrite 60 mg45 mg IV of sodium nitrite (n=500) or 60 mg IV sodium nitrite (n=500) given during active resuscitation from out of hospital cardiac arrest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cardiac arrest, either VF or non-VF, patients receiving ACLS by paramedics
- IV or IO access
- Comatose
Key exclusion criteria (3 listed)
- traumatic cause of cardiac arrest
- prisoner, pregnancy
- known DNAR
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 |
|---|---|---|
| Placebo500 patients will 2 ml of normal saline | Drug | Placebo |
| sodium nitrite 45 mg500 patients will receive 45 mg IV sodium nitrite | Drug | sodium nitrite |
| sodium nitrite 60 mg500 patients will receive a dose of 60 mg IV sodium nitrite | Drug | sodium nitrite |
Primary outcome
Number of Participants Who Survived to Hospital Admission
Time frame: within 24 hours after out of hospital cardiac arrest
Patient has sustained pulse at arrival to the emergency department
6 secondary outcomes
Survival to Discharge
Time frame: within 3-6 months after cardiac arrest
Number of Days in ICU
Time frame: Within first 3 months of hospital admission
Survival to 24 Hours
Time frame: within first 24 h after hospital admission
Re-arrest
Time frame: before hospital arrival
Survival to 48 Hours After Admission to Hospital
Time frame: within first 48 hours after admission to hospital
Survival to 72 Hours After Admission to Hospital
Time frame: within first 72 hours after admission to hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33433575Kim F, Maynard C, Dezfulian C, Sayre M, Kudenchuk P, Rea T, Sampson D, Olsufka M, May S, Nichol G. Effect of Out-of-Hospital Sodium Nitrite on Survival to Hospital Admission After Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Jan 12;325(2):138-145. doi: 10.1001/jama.2020.24326.
- Individual participant dataSharing planned: Undecided
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Cardiac Arrest, Out-Of-Hospital
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.
Francis Kim, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sodium nitrite 45 mg and sodium nitrite 60 mg in people with Out-Of-Hospital Cardiac Arrest, run by University of Washington at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Survived to Hospital Admission (time frame: within 24 hours after out of hospital cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03452917, which also lists 1 linked publication.
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 24 May 2023.