NCT02987088

Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Out-Of-Hospital Cardiac Arrest

Interventions

Type	Name	Description
DRUG	Sodium Nitrite

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-04-05
• Completion: 2017-05-02
• First posted: 2016-12-08
• Last updated: 2018-05-07

Locations

1 site across 1 country: United States