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

Completed · Phase 1

Conditions studied: Out-Of-Hospital Cardiac Arrest

In brief

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

Key facts

Study ID

NCT02987088

Run by

University of Washington

People needed

120

Starts

2016-12-01

Expected to finish

2017-05-02

Last updated by the study team

2018-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Intravenous access/intraosseous access
• Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics.
• Age 18 years or older
• Comatose

You may not qualify if…

• Traumatic cause of cardiac arrest
• Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
• Known DNAR
• Drowning as cause of arrest.

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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