Out-Of-Hospital Cardiac Arrest
Conditions
Brief 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 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
Interventions
DRUGSodium Nitrite
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma level of sodium nitrite at hospital arrival | 15-45 minutes after dose has been given |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| blood pressure at hospital arrival | at hospital arrival usually 15-60 minutes after cardiac arrest |
Countries
United States
Outcome results
None listed