Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Out-Of-Hospital Cardiac Arrest Clinical Trial

— SNOCAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452917
• Other study ID #: 51605
• Secondary ID: R01HL129722
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 8, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: April 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1502
• Est. completion date: April 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Drug:
• Placebo
500 patients will 2 ml of normal saline
• sodium nitrite 45 mg
500 patients will receive 45 mg IV sodium nitrite
• sodium nitrite 60 mg
500 patients will receive a dose of 60 mg IV sodium nitrite

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Survived to Hospital Admission	Patient has sustained pulse at arrival to the emergency department	within 24 hours after out of hospital cardiac arrest
Secondary	Survival to Discharge	Patient alive at time of discharge from hospital	within 3-6 months after cardiac arrest
Secondary	Number of Days in ICU	Number of days the patient is admitted to the Intensive Care Unit	Within first 3 months of hospital admission
Secondary	Survival to 24 Hours	Patient is alive after the first 24 hours after admission to the hospital	within first 24 h after hospital admission
Secondary	Re-arrest	Patient loses pulses during transport to the hospital. Event occurs before admission to hospital.	before hospital arrival
Secondary	Survival to 48 Hours After Admission to Hospital	Patient is alive after first 48 hours after admission to the hospital	within first 48 hours after admission to hospital
Secondary	Survival to 72 Hours After Admission to Hospital	Patient is alive after first 72 hours after admission to the hospital	within first 72 hours after admission to hospital