Naloxone for Opioid Associated Out of Hospital Cardiac Arrest
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Survival to hospital discharge
研究概览
简要总结
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.
详细描述
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 circulatory effects of opioids. Naloxone improves cardiac arrest outcomes in animals, and a recent retrospective analysis of cardiac arrests from 1300 EMS agencies found that survival and return of spontaneous circulation (ROSC) were higher in those given naloxone compared to those not receiving naloxone in patients presenting in PEA. Whether naloxone benefits patients in OA-OHCA is a knowledge gap that should be assessed in a randomized controlled trial.
The long-term goal is to conduct Naloxone for Opioid Associated Out of Hospital Cardiac Arrest (NOPACA), a randomized, controlled trial to determine the efficacy of naloxone vs. placebo in OA-OHCA. 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 adequate retention and measurement of outcomes at follow up.
Hypothesis: The overall hypothesis is that early EMS administration of naloxone (in addition to standard resuscitation) improves survival in patients in OA-OHCA. The hypothesis of the pilot RCT is that the investigators can feasibly enroll, randomize, administer naloxone, and measure ROSC and survival at hospital discharge.
Aim 1: Determine the ability to enroll and randomize participants into a RCT of naloxone vs. placebo for OA-OHCA.
Aim 2: Determine the ability to deliver the treatments per protocol, after standard initial resuscitation measures (within 5 minutes of initiating CPR and giving the first dose of epinephrine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Patient experiences ROSC prior to study drug administration
- •Prior inclusion in the study
- •Patient has an opt out bracelet or family member states exclusion •. Children less than 18 years old
研究组 & 干预措施
Naloxone
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.
干预措施: Naloxone 2 MG (Drug)
Saline
Saline 2ml will be supplied in pre-filled syringes within numbered trial treatment packs. The trial will be double-blind; patients, investigators, and the clinical team will be blinded. Only the pharmacy providing the numbered syringes will be aware of the allocation but will not be involved with clinical care or outcome evaluation. The saline placebo will be stored in syringes identical to the naloxone syringes without identifying features.
干预措施: Saline 2ml (Drug)
结局指标
主要结局
Survival to hospital discharge
时间窗: Through hospital discharge, an average of up to 5 days
Survival to hospital discharge is defined as patient is discharged from the hospital acute care unit alive regardless of neurological status, outcome or destination.
次要结局
- Sustained Return of Spontaneous Circulation (ROSC)(Through completion of the index EMS encounter, an average of 30 minutes)