Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

NCT03452917 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 51605R01HL129722
• Study Type: interventional
• Target: 1,502
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Survival to Discharge

  within 3-6 months after cardiac arrest

• Number of Days in ICU

  Within first 3 months of hospital admission

• Survival to 24 Hours

  within first 24 h after hospital admission

• Re-arrest

  before hospital arrival

• Survival to 48 Hours After Admission to Hospital

  within first 48 hours after admission to hospital

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 ml of normal saline (n=500)

Drug: Placebo

sodium nitrite

EXPERIMENTAL

45 mg IV of sodium nitrite (n=500) or 60 mg IV sodium nitrite (n=500) given during active resuscitation from out of hospital cardiac arrest.

Drug: sodium nitrite 45 mg; Drug: sodium nitrite 60 mg

Interventions

Placebo DRUG

500 patients will 2 ml of normal saline

Placebo

sodium nitrite 45 mg DRUG

500 patients will receive 45 mg IV sodium nitrite

sodium nitrite

sodium nitrite 60 mg DRUG

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

sodium nitrite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac arrest, either VF or non-VF, patients receiving ACLS by paramedics
• IV or IO access
• Comatose

You may not qualify if:

• traumatic cause of cardiac arrest
• prisoner, pregnancy
• known DNAR

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 33433575 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitrites; Nitrous Acid; Nitrogen Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Francis Kim
• Organization: University of Washington

fkim@u.washington.edu

206-897-5264

Study Officials

• Francis Kim, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine/Division of Cardiology

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 2, 2018
• Study Start: February 8, 2018
• Primary Completion: December 31, 2019
• Study Completion: April 30, 2020
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2023-04

Locations

US (1)