Out-Of-Hospital Cardiac ArrestPhase 1NCT02987088
Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
A Phase 1 study testing Sodium Nitrite in people with Out-Of-Hospital Cardiac Arrest, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival. Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on… 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
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 2 May 2017
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intravenous access/intraosseous access
- Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics.
- Age 18 years or older
- Comatose
Who cannot join
- Traumatic cause of cardiac arrest
- Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
- Known DNAR
- Drowning as cause of arrest.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival.
Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV administered during resuscitation will achieve plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either decreasing or increasing, will be made if necessary permitting us to determine the optimal nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Sodium Nitrite
- 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.
Sodium NitriteDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma level of sodium nitrite at hospital arrival
Measured: 15-45 minutes after dose has been given
Secondary outcomes (2)
Rate of re-arrest
Measured: 15-120 minutes after dose has been given
Need for pressor support before hospital arrival
Measured: 15-120 minutes after dose has been given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion5 Apr 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- 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
- NCT02987088
- Sponsor's protocol ID
- 51605-A
- Status last verified
- May 2018
- First submitted
- 3 Dec 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kim F, Dezfulian C, Empey PE, Morrell M, Olsufka M, Scruggs S, Kudenchuk P, May S, Maynard C, Sayre MR, Nichol G. Usefulness of Intravenous Sodium Nitrite During Resuscitation for the Treatment of Out-of-Hospital Cardiac Arrest. Am J Cardiol. 2018 Aug 15;122(4):554-559. doi: 10.1016/j.amjcard.2018.04.060. Epub 2018 Jun 20.
PubMed 30205886
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02987088
- Acronym / sponsor ID
- 51605-A
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- 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.
The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival.
Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV administered during resuscitation will achieve plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either decreasing or increasing, will be made if necessary permitting us to determine the optimal nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intravenous access/intraosseous access
- Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics.
- Age 18 years or older
- Comatose
Key exclusion criteria (4 listed)
- Traumatic cause of cardiac arrest
- Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
- Known DNAR
- Drowning as cause of arrest.
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 |
|---|---|---|
| Sodium Nitrite | Drug | – |
Primary outcome
plasma level of sodium nitrite at hospital arrival
Time frame: 15-45 minutes after dose has been given
2 secondary outcomes
Rate of re-arrest
Time frame: 15-120 minutes after dose has been given
Need for pressor support before hospital arrival
Time frame: 15-120 minutes after dose has been given
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Derived from this study: PubMed 30205886Kim F, Dezfulian C, Empey PE, Morrell M, Olsufka M, Scruggs S, Kudenchuk P, May S, Maynard C, Sayre MR, Nichol G. Usefulness of Intravenous Sodium Nitrite During Resuscitation for the Treatment of Out-of-Hospital Cardiac Arrest. Am J Cardiol. 2018 Aug 15;122(4):554-559. doi: 10.1016/j.amjcard.2018.04.060. Epub 2018 Jun 20.
- Individual participant dataSharing planned: No
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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.
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 1 study testing Sodium Nitrite 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 4 inclusion and 4 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 7 May 2018. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
plasma level of sodium nitrite at hospital arrival (time frame: 15-45 minutes after dose has been given). 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 NCT02987088, 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 7 May 2018.