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

May 1, 2018 updated by: Francis Kim, University of Washington

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Intravenous access/intraosseous access
  2. Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma level of sodium nitrite at hospital arrival
Time Frame: 15-45 minutes after dose has been given
15-45 minutes after dose has been given

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of re-arrest
Time Frame: 15-120 minutes after dose has been given
15-120 minutes after dose has been given
Need for pressor support before hospital arrival
Time Frame: 15-120 minutes after dose has been given
15-120 minutes after dose has been given

Other Outcome Measures

Outcome Measure
Time Frame
blood pressure at hospital arrival
Time Frame: at hospital arrival usually 15-60 minutes after cardiac arrest
at hospital arrival usually 15-60 minutes after cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

April 5, 2017

Study Completion (ACTUAL)

May 2, 2017

Study Registration Dates

First Submitted

December 3, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (ESTIMATE)

December 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51605-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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