Clinical trial

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

Name

51605

Description

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.

Trial arms

Trial start

2018-02-08

Estimated PCD

2019-12-31

Trial end

2020-04-30

Status

Completed

Phase

Early phase I

Treatment

Placebo

500 patients will 2 ml of normal saline

Arms:

Placebo

sodium nitrite 45 mg

500 patients will receive 45 mg IV sodium nitrite

Arms:

sodium nitrite

sodium nitrite 60 mg

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

Arms:

sodium nitrite

Size

1502

Primary endpoint

Number of Participants Who Survived to Hospital Admission

within 24 hours after out of hospital cardiac arrest

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1502, 'type': 'ACTUAL'}}

Updated at

2023-05-24

1 organization

1 product

1 drug

1 indication

Organization

University of Washington

Drug

Varlilumab

Indication

Cardiac Arrest

Product

Sodium Nitrite