Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest (SNOCAT)

University of Washington

Status and phase: Completed; Phase 3; Phase 2

Conditions: Out-Of-Hospital Cardiac Arrest

Treatments: Drug: sodium nitrite 45 mg; Drug: sodium nitrite 60 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03452917

51605

R01HL129722 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. The primary outcome will be proportion of patients surviving to hospital admission.

Full description

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.

Enrollment: 1,502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,502 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 ml of normal saline (n=500)

Treatment:

Drug: Placebo

sodium nitrite

Experimental group

Description:

45 mg IV of sodium nitrite (n=500) or 60 mg IV sodium nitrite (n=500) given during active resuscitation from out of hospital cardiac arrest.

Treatment:

Drug: sodium nitrite 45 mg

Drug: sodium nitrite 60 mg