CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,502 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
sodium nitrite 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03452917
NCT03452917Phase 3Completed
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Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

University of Washington·interventional·Posted Mar 2, 2018·Updated May 24, 2023

In Brief

A Phase 3 clinical trial evaluating Placebo, sodium nitrite 45 mg, and 1 other intervention for Out-Of-Hospital Cardiac Arrest. Completed, enrolled 1,502 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOut-Of-Hospital Cardiac Arrest
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 2, 2018
Enrollment StartFeb 8, 2018
Primary CompletionDec 31, 2019
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.3 years ago

Interventions

Placebodrug

500 patients will 2 ml of normal saline

sodium nitrite 45 mgdrug

500 patients will receive 45 mg IV sodium nitrite

sodium nitrite 60 mgdrug

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