Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Sponsor
- University of Washington
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- plasma level of sodium nitrite at hospital arrival
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Francis Kim
Associate Professor, Medicine/Division of Cardiology
University of Washington
Eligibility Criteria
Inclusion Criteria
- •Intravenous access/intraosseous access
- •Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics.
- •Age 18 years or older
Exclusion Criteria
- •Traumatic cause of cardiac arrest
- •Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
- •Drowning as cause of arrest.
Outcomes
Primary Outcomes
plasma level of sodium nitrite at hospital arrival
Time Frame: 15-45 minutes after dose has been given
Secondary Outcomes
- 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)