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.
The hemodynamic effects of the optimal dose of IV nitrite administered in patients with cardiac arrest are unknown. A significant negative hemodynamic effect from nitrite would decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or increase the need for vasopressor support in the field. In Seattle/King County, typically 40% of out-of-hospital cardiac arrest patients attended to by paramedics have Return of spontaneous circulation (ROSC) and are admitted to the hospital. In this study, 1500 patients with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be randomized to receive placebo (n=500) or 45 mg IV (n=500) or 60 mg dose (n=500) of sodium nitrite. The study will have 80% power to detect an absolute increase in hospital admission rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60 mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40% in the placebo group and with one interim analysis and stopping only for potential futility and/or harm). The investigators will examine the proportion of patients who survive to discharge as a secondary measure of efficacy. Patients will be eligible for this study if: 1. Intravenous access (IV)/intraosseous access(IO) 2. Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving Advanced Cardiac Life Support (ACLS) by Seattle/King County 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,502
500 patients will 2 ml of normal saline
500 patients will receive 45 mg IV sodium nitrite
500 patients will receive a dose of 60 mg IV sodium nitrite
Harborview Medical Center
Seattle, Washington, United States
Number of Participants Who Survived to Hospital Admission
Patient has sustained pulse at arrival to the emergency department
Time frame: within 24 hours after out of hospital cardiac arrest
Survival to Discharge
Patient alive at time of discharge from hospital
Time frame: within 3-6 months after cardiac arrest
Number of Days in ICU
Number of days the patient is admitted to the Intensive Care Unit
Time frame: Within first 3 months of hospital admission
Survival to 24 Hours
Patient is alive after the first 24 hours after admission to the hospital
Time frame: within first 24 h after hospital admission
Re-arrest
Patient loses pulses during transport to the hospital. Event occurs before admission to hospital.
Time frame: before hospital arrival
Survival to 48 Hours After Admission to Hospital
Patient is alive after first 48 hours after admission to the hospital
Time frame: within first 48 hours after admission to hospital
Survival to 72 Hours After Admission to Hospital
Patient is alive after first 72 hours after admission to the hospital
Time frame: within first 72 hours after admission to hospital
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