Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

NCT ID: NCT03452917

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2020-04-30

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.

Detailed Description

The hemodynamic effects of the optimal dose of IV nitrite administered in patients with cardiac arrest are unknown. A significant negative hemodynamic effect from nitrite would decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or increase the need for vasopressor support in the field. In Seattle/King County, typically 40% of out-of-hospital cardiac arrest patients attended to by paramedics have Return of spontaneous circulation (ROSC) and are admitted to the hospital. In this study, 1500 patients with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be randomized to receive placebo (n=500) or 45 mg IV (n=500) or 60 mg dose (n=500) of sodium nitrite. The study will have 80% power to detect an absolute increase in hospital admission rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60 mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40% in the placebo group and with one interim analysis and stopping only for potential futility and/or harm). The investigators will examine the proportion of patients who survive to discharge as a secondary measure of efficacy.

Patients will be eligible for this study if:

1. Intravenous access (IV)/intraosseous access(IO)

2. Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving Advanced Cardiac Life Support (ACLS) by Seattle/King County paramedics.

3. Age 18 years or older

4. Comatose

Exclusion Criteria

1. Traumatic cause of cardiac arrest

2. Prisoner, pregnancy, age less than 18 (special population/vulnerable population)

3. Known DNAR

4. Drowning as cause of arrest.

Conditions

Out-Of-Hospital Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

2 ml of normal saline (n=500)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

500 patients will 2 ml of normal saline

sodium nitrite

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.

Group Type: EXPERIMENTAL

sodium nitrite 45 mg

Intervention Type: DRUG

500 patients will receive 45 mg IV sodium nitrite

sodium nitrite 60 mg

Intervention Type: DRUG

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

Interventions

Placebo

500 patients will 2 ml of normal saline

Intervention Type: DRUG

sodium nitrite 45 mg

500 patients will receive 45 mg IV sodium nitrite

Intervention Type: DRUG

sodium nitrite 60 mg

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Francis Kim

Professor, Medicine/Division of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francis Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33433575 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HL129722

Identifier Type: NIH

Identifier Source: secondary_id

View Link

51605

Identifier Type: -

Identifier Source: org_study_id