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Naloxone for Opioid Associated Out of Hospital Cardiac Arrest

ConditionsHeart Arrest, Out-Of-HospitalOpioid OverdoseNaloxone
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Naloxone 2 MG

    Drug

    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.

  • Saline 2ml

    Drug

    Placebo

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: NaloxoneActive comparator 1 intervention
Group B: SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Survival to hospital discharge

Survival to hospital discharge is defined as patient is discharged from the hospital acute care unit alive regardless of neurological status, outcome or destination.

Time frame
Through hospital discharge, an average of up to 5 days

Secondary outcomes

1

Sustained Return of Spontaneous Circulation (ROSC)

Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes or with pulse at time of transfer of care to the ED.

Time frame
Through completion of the index EMS encounter, an average of 30 minutes

Other outcomes

1

Sufficient subjects to conduct the trial

Number of EMS treated OHCA patients who meet inclusion criteria per month

Time frame
Monthly, throughout duration of the trial
2

Proportion of OHCA eligible for study

Proportion of all EMS OHCA cases that meet all inclusion criteria and no exclusion criteria

Time frame
Monthly, throughout duration of the trial
3

Study Drug administration compliance

Proportion of those randomized participants who receive the study drug based on randomization assignment, with a target treatment fidelity ≥ 75%.

Time frame
Between time of randomization and end of EMS encounter, an average of 30 minutes
4

Participant retention

Proportion of randomized participants who are retained in the study, with a goal of retention and ascertainment of outcomes in ≥ 75% of participants.

Time frame
Through study completion and outcome ascertainment, and average of up to 5 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov

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