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Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

NCT03452917 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1502

Last updated 2023-05-24

Study results available
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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.

Conditions

  • Out-Of-Hospital Cardiac Arrest

Interventions

DRUG

Placebo

500 patients will 2 ml of normal saline

DRUG

sodium nitrite 45 mg

500 patients will receive 45 mg IV sodium nitrite

DRUG

sodium nitrite 60 mg

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

Sponsors & Collaborators

Principal Investigators

  • Francis Kim, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2019-12-31
Completion
2020-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452917 on ClinicalTrials.gov