Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

The hemodynamic effects of the optimal dose of IV nitrite administered in patients with
cardiac arrest are unknown. A significant negative hemodynamic effect from nitrite would
decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or
increase the need for vasopressor support in the field. In Seattle/King County, typically 40%
of out-of-hospital cardiac arrest patients attended to by paramedics have Return of
spontaneous circulation (ROSC) and are admitted to the hospital. In this study, 1500 patients
with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be
randomized to receive placebo (n=500) or 45 mg IV (n=500) or 60 mg dose (n=500) of sodium
nitrite. The study will have 80% power to detect an absolute increase in hospital admission
rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60
mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40%
in the placebo group and with one interim analysis and stopping only for potential futility
and/or harm). The investigators will examine the proportion of patients who survive to
discharge as a secondary measure of efficacy.

Patients will be eligible for this study if:

1. Intravenous access (IV)/intraosseous access(IO)

2. Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving
Advanced Cardiac Life Support (ACLS) by Seattle/King County paramedics.

3. Age 18 years or older

4. Comatose

Exclusion Criteria

1. Traumatic cause of cardiac arrest

2. Prisoner, pregnancy, age less than 18 (special population/vulnerable population)

3. Known DNAR

4. Drowning as cause of arrest.

Inclusion Criteria:

- Cardiac arrest, either VF or non-VF, patients receiving ACLS by paramedics

- IV or IO access

- Comatose

Exclusion Criteria:

- traumatic cause of cardiac arrest

- prisoner, pregnancy

- known DNAR