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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Nitrite | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| plasma level of sodium nitrite at hospital arrival | 15-45 minutes after dose has been given |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of re-arrest | 15-120 minutes after dose has been given | |
| Need for pressor support before hospital arrival | 15-120 minutes after dose has been given |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure at hospital arrival | at hospital arrival usually 15-60 minutes after cardiac arrest |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Kim, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30205886 | Derived | 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. |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012977 | Sodium Nitrite |
| ID | Term |
|---|---|
| D009573 | Nitrites |
| D009608 | Nitrous Acid |
| D017672 | Nitrogen Compounds |
| D007287 | Inorganic Chemicals |
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| D017670 |
| Sodium Compounds |