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NCT Number: NCT03452917

Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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:

  • Intravenous access (IV)/intraosseous access(IO)
  • Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving Advanced Cardiac Life Support (ACLS) by Seattle/King County paramedics.
  • Age 18 years or older
  • Comatose

Exclusion criteria

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

500 patients will 2 ml of normal saline

sodium nitrite 45 mg

Drug

500 patients will receive 45 mg IV sodium nitrite

sodium nitrite 60 mg

Drug

500 patients will receive a dose of 60 mg IV sodium nitrite

Primary outcomes

  1. Number of Participants Who Survived to Hospital Admission

    Time frame: within 24 hours after out of hospital cardiac arrest

    Patient has sustained pulse at arrival to the emergency department

Secondary outcomes

  1. Survival to Discharge

    Time frame: within 3-6 months after cardiac arrest

    Patient alive at time of discharge from hospital

  2. Number of Days in ICU

    Time frame: Within first 3 months of hospital admission

    Number of days the patient is admitted to the Intensive Care Unit

  3. Survival to 24 Hours

    Time frame: within first 24 h after hospital admission

    Patient is alive after the first 24 hours after admission to the hospital

  4. Re-arrest

    Time frame: before hospital arrival

    Patient loses pulses during transport to the hospital. Event occurs before admission to hospital.

  5. Survival to 48 Hours After Admission to Hospital

    Time frame: within first 48 hours after admission to hospital

    Patient is alive after first 48 hours after admission to the hospital

  6. Survival to 72 Hours After Admission to Hospital

    Time frame: within first 72 hours after admission to hospital

    Patient is alive after first 72 hours after admission to the hospital

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Acronym: SNOCAT

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 2, 2018
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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