Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 3, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2017
CompletedMay 7, 2018
May 1, 2018
4 months
December 3, 2016
May 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
plasma level of sodium nitrite at hospital arrival
15-45 minutes after dose has been given
Secondary Outcomes (2)
Rate of re-arrest
15-120 minutes after dose has been given
Need for pressor support before hospital arrival
15-120 minutes after dose has been given
Other Outcomes (1)
blood pressure at hospital arrival
at hospital arrival usually 15-60 minutes after cardiac arrest
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Traumatic cause of cardiac arrest
- Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
- Known DNAR
- Drowning as cause of arrest.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 30205886DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis Kim, MD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Medicine/Division of Cardiology
Study Record Dates
First Submitted
December 3, 2016
First Posted
December 8, 2016
Study Start
December 1, 2016
Primary Completion
April 5, 2017
Study Completion
May 2, 2017
Last Updated
May 7, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share