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The Effect of Prehospital Combination of Epinephrine, Vasopressin, and Steroid in OHCA

ConditionsCardiac ArrestOut-Of-Hospital Cardiac ArrestEmergency Medical Services
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

This project is a randomized controlled clinical research design, The hypothesis P-I-C-O of the study is: For adult patients in the Taipei City and New Taipei City communities who have suffered sudden non-traumatic death and have been resuscitated by advanced paramedics, the intervention group that receives combined drug treatment (epinephrine, vasopressin, methylprednisolone) has a better rate of sustained recovery of spontaneous circulation (ROSC) (primary outcome) and long-term survival status (secondary outcomes) compared to the control group that receives single drug treatment (epinephrine).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (aged >= 18 )

Out-of-hospital cardiac arrest in the studied regions

Treated by paramedics authorized and capable of giving prehospital medication

Disqualifiers

OHCA with traumatic etiology

Obvious signs of death like decapitation, rigor mortis, livor mortis, decomposition, etc.

DNR (Do Not Resuscitation) or termination of resuscitation requested by the family

Patients with known or suspected pregnancy

Trial design

Design model

Crossover

Treatments tested in this trial

  • Combination group

    Drug

    Combination of epinephrine (Adrenaline® 1mg/vial) every 3-5 minutes, vasopressin (Pitressin® 20Unints/vial) every 3-5 minutes up to 4 vials (a total of 80Units), methylprednisolone (Solu-Medrol® 40mg/vial)

  • Standard group

    Drug

    standard doses of epinephrine (Adrenaline® 1mg/vial) every 3-5 minutes

Treatment groups

1,344 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of sustained return of spontaneous circulation (ROSC)

Return of spontaneous circulation (ROSC) is the restart of a sustained heart rhythm measured by pulsation and vital signs that permeate the body after a cardiac arrest. Sustained ROSC ≥ 2 hours has been used as an surrogate to survival to hospital admission in many overcrowded emergency departments (ED).

Time frame
estimated 2 hours

Secondary outcomes

1

Rate of prehospital return of spontaneous circulation (ROSC)

presence of ROSC prior to arrival at emergency department (ED)

Time frame
estimated 1 hour
2

Rate of survival to hospital discharge

survival to hospital admission, and without in-hospital death

Time frame
estimated 30 days
3

Rate of survival with favorable neurologic status

Good neurologic status (defined as Cerebral-Performance Category (CPC) score 1 and 2) at hospital discharge

Time frame
estimated 30 days

Other outcomes

Sponsors and contacts

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

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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