Out-Of-Hospital Cardiac Arrest Clinical Trial
— SNOCATOfficial title:
Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Verified date | April 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1502 |
Est. completion date | April 30, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Harborview Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Survived to Hospital Admission | Patient has sustained pulse at arrival to the emergency department | within 24 hours after out of hospital cardiac arrest | |
Secondary | Survival to Discharge | Patient alive at time of discharge from hospital | within 3-6 months after cardiac arrest | |
Secondary | Number of Days in ICU | Number of days the patient is admitted to the Intensive Care Unit | Within first 3 months of hospital admission | |
Secondary | Survival to 24 Hours | Patient is alive after the first 24 hours after admission to the hospital | within first 24 h after hospital admission | |
Secondary | Re-arrest | Patient loses pulses during transport to the hospital. Event occurs before admission to hospital. | before hospital arrival | |
Secondary | Survival to 48 Hours After Admission to Hospital | Patient is alive after first 48 hours after admission to the hospital | within first 48 hours after admission to hospital | |
Secondary | Survival to 72 Hours After Admission to Hospital | Patient is alive after first 72 hours after admission to the hospital | within first 72 hours after admission to hospital |
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