Clinical Trial: Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
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
Detailed Summary:
Sponsor: University of Washington
Current Primary Outcome: plasma level of sodium nitrite at hospital arrival [ Time Frame: 15-45 minutes after dose has been given ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rate of re-arrest [ Time Frame: 15-120 minutes after dose has been given ]
- Need for pressor support before hospital arrival [ Time Frame: 15-120 minutes after dose has been given ]
Original Secondary Outcome: Same as current
Information By: University of Washington
Dates:
Date Received: December 3, 2016
Date Started: December 2016
Date Completion:
Last Updated: May 16, 2017
Last Verified: December 2016
