Naloxone for Opioid Associated Out of Hospital Cardiac Arrest
University of California, San Francisco
Summary
The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to randomize patients in OHCA to early naloxone administration vs. placebo after initial resuscitation and measure ROSC and survival. Challenges to designing NOPACA include uncertainty regarding: 1) the available pool of participants and number of EMS agencies needed to meet enrollment targets; 2) acceptability among patients, EMS and Emergency Medicine provider stakeholders, and 3) estimates of the study outcomes needed for sample size estimates. Toward obtaining the necessary information to design NOPACA, the investigators propose a pilot RCT of participants at high risk for OA-OHCA to verify a reasonable recruitment rate; treatment fidelity and acceptability; and adequate retention and measurement of outcomes at follow up. The investigators propose incorporating hypothesis testing of the feasibility outcomes to determine progression to a definitive trial.
Description
Rationale: Opioid associated out-of-hospital cardiac arrest (OA-OHCA) is defined as cardiac arrest precipitated by the use of opioids, with or without co-intoxicants and comorbidities. In OA-OHCA, hypoxia is thought reduce cardiac output, resulting in hypotension, bradycardia, and pulseless electric activity (PEA) or asystole. This pathophysiology is distinct from sudden cardiac death and other arrest etiologies and may benefit from targeted treatments, including naloxone. Naloxone is a competitive mu opioid-receptor antagonist that reverses the central nervous system, respiratory, and circula…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients will be eligible if all the following criteria are met: • Adults (age ≥ 18 years) in OHCA per EMS protocol. ACLS interventions have been initiated by EMS: chest compressions, ventilation; • 1st dose of epinephrine given via IV or IO. •. At risk of OA-OHCA (EMS presumed drug-related OHCA or NACARDI positive for occult OA-OHCA) as described above. Exclusion Criteria: * EMS plans to administer naloxone, or administration of naloxone by EMS during the same encounter * Cardiac arrest apparently caused by trauma, choking, or drowning. * Known or apparent pregnancy *…
Interventions
- DrugNaloxone 2 MG
The intervention consists of naloxone 2mg (2ml of 1mg/ml solution) administered by EMS personnel via the IV or IO route. The study intervention will be administered immediately (within 5 minutes) following the first dose of epinephrine. When naloxone hydrochloride is administered intravenously, the onset of action is generally apparent within two minutes. The naloxone will be administered following the first dose of epinephrine. The control is saline 2ml will be supplied in pre-filled syringes within numbered trial treatment packs. They will be identical in appearance to the naloxone syringes.
- DrugSaline 2ml
Placebo
Location
- University of California, San FranciscoSan Francisco, California