Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

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.

Timeline

Start

2018-02-08

Primary completion

2019-12-31

Completion

2020-04-30

Outcome

Missed primary endpoint

paper administration of sodium nitrite, compared with placebo, did not significantly improve survival to hospital admission. PMID 33433575 ↗

registry Placebo vs Sodium Nitrite 45 mg; p = 0.82; Mean Difference (Final Values) -2.9 NCT03452917 ↗

registry Placebo vs Sodium Nitrite 60 mg; p = 0.66; Mean Difference (Final Values) -1.3 NCT03452917 ↗

Publications

• Kim F, Maynard C, Dezfulian C, Sayre M, Kudenchuk P, Rea T, Sampson D, Olsufka M, May S, Nichol G. Effect of Out-of-Hospital Sodium Nitrite on Survival to Hospital Admission After Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Jan 12;325(2):138-145. doi: 10.1001/jama.2020.24326.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Nitrite	Small molecule	45 mg	Intravenous
Subject	Sodium Nitrite	Small molecule	60 mg	Intravenous

Indications