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NCT02987088 Clinical Trial

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

Out-Of-Hospital Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02987088
Other study ID # 51605-A
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2016
Est. completion date May 2, 2017

Study information
Verified date May 2018
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date May 2, 2017
Est. primary completion date April 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sodium Nitrite

Locations
Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other blood pressure at hospital arrival at hospital arrival usually 15-60 minutes after cardiac arrest
Primary plasma level of sodium nitrite at hospital arrival 15-45 minutes after dose has been given
Secondary Rate of re-arrest 15-120 minutes after dose has been given
Secondary Need for pressor support before hospital arrival 15-120 minutes after dose has been given
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