Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/9/2018 |
| Start Date: | December 2016 |
| End Date: | May 2, 2017 |
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
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
Inclusion Criteria:
1. Intravenous access/intraosseous access
2. Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One
paramedics.
3. Age 18 years or older
4. Comatose
Exclusion Criteria:
1. Traumatic cause of cardiac arrest
2. Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
3. Known DNAR
4. Drowning as cause of arrest.
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