Phase 3
N=1,497
Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Out-Of-Hospital Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT03452917 ↗Enrolled (actual)
1,497
Serious AEs
53.4%
Results posted
May 2023
Primary outcome: Primary: Number of Participants Who Survived to Hospital Admission — 218; 205; 212 Participants — p=0.82
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); sodium nitrite 45 mg (Drug); sodium nitrite 60 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Survived to Hospital Admission |
218; 205; 212 | 0.82 |
| SECONDARY Survival to Discharge |
74; 66; 72 | 0.44 |
| SECONDARY Number of Days in ICU |
6.7; 8.9; 7.3 | 0.12 |
| SECONDARY Survival to 24 Hours |
181; 170; 171 | 0.42 |
| SECONDARY Re-arrest |
139; 130; 156 | 0.93 |
| SECONDARY Survival to 48 Hours After Admission to Hospital |
161; 152; 151 | 0.50 |
| SECONDARY Survival to 72 Hours After Admission to Hospital |
142; 133; 131 | 0.49 |
Summary
In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. The primary outcome will be proportion of patients surviving to hospital admission.
Eligibility Criteria
Inclusion Criteria
- Cardiac arrest, either VF or non-VF, patients receiving ACLS by paramedics
- IV or IO access
- Comatose
Exclusion Criteria
- traumatic cause of cardiac arrest
- prisoner, pregnancy
- known DNAR
Data sourced from ClinicalTrials.gov (NCT03452917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.