Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Status:
Completed
Trial end date:
2017-05-02
Target enrollment:
Participant gender:
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