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Completed

NCT Number: NCT02987088

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

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

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Nitrite

Drug

Primary outcomes

  1. plasma level of sodium nitrite at hospital arrival

    Time frame: 15-45 minutes after dose has been given

Secondary outcomes

  1. Rate of re-arrest

    Time frame: 15-120 minutes after dose has been given

  2. Need for pressor support before hospital arrival

    Time frame: 15-120 minutes after dose has been given

Other outcomes

  1. blood pressure at hospital arrival

    Time frame: at hospital arrival usually 15-60 minutes after cardiac arrest

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2016
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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