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Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Primary Purpose

Out-Of-Hospital Cardiac Arrest

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sodium Nitrite

About this trial

This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Intravenous access/intraosseous access
Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics.
Age 18 years or older
Comatose

Exclusion Criteria:

Traumatic cause of cardiac arrest
Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
Known DNAR
Drowning as cause of arrest.

Sites / Locations

University of Washington

Outcomes

Primary Outcome Measures

plasma level of sodium nitrite at hospital arrival

Secondary Outcome Measures

Rate of re-arrest

Need for pressor support before hospital arrival

Full Information

NCT ID

NCT02987088

First Posted

December 3, 2016

Last Updated

May 1, 2018

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT02987088

Brief Title

Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Official Title

Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

December 2016 (undefined)

Primary Completion Date

April 5, 2017 (Actual)

Study Completion Date

May 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival. Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV administered during resuscitation will achieve plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either decreasing or increasing, will be made if necessary permitting us to determine the optimal nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Out-Of-Hospital Cardiac Arrest

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sodium Nitrite

Primary Outcome Measure Information:

Title

plasma level of sodium nitrite at hospital arrival

Time Frame

15-45 minutes after dose has been given

Secondary Outcome Measure Information:

Title

Rate of re-arrest

Time Frame

15-120 minutes after dose has been given

Title

Need for pressor support before hospital arrival

Time Frame

15-120 minutes after dose has been given

Other Pre-specified Outcome Measures:

Title

blood pressure at hospital arrival

Time Frame

at hospital arrival usually 15-60 minutes after cardiac arrest

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Intravenous access/intraosseous access Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics. Age 18 years or older Comatose Exclusion Criteria: Traumatic cause of cardiac arrest Prisoner, pregnancy, age less than 18 (special population/vulnerable population) Known DNAR Drowning as cause of arrest.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis Kim, MD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30205886

Citation

Kim F, Dezfulian C, Empey PE, Morrell M, Olsufka M, Scruggs S, Kudenchuk P, May S, Maynard C, Sayre MR, Nichol G. Usefulness of Intravenous Sodium Nitrite During Resuscitation for the Treatment of Out-of-Hospital Cardiac Arrest. Am J Cardiol. 2018 Aug 15;122(4):554-559. doi: 10.1016/j.amjcard.2018.04.060. Epub 2018 Jun 20.

Results Reference

derived

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Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

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