RecruitingNot ApplicableNCT06203847

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

A Randomized Clinical Trial of Patient Outcomes Following Out-of-Hospital Cardiac Arrest Receiving Epinephrine Versus In-together Vasopressin, Epinephrine, and Steroid. (OHCA REVIVES Trial)


Sponsor

National Taiwan University Hospital

Enrollment

1,344 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • Adult patients (aged >= 18 )
  • Out-of-hospital cardiac arrest in the studied regions
  • Treated by paramedics authorized and capable of giving prehospital medication

Exclusion Criteria8

  • 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
  • No vascular access was established before hospital arrival
  • ROSC before the administrated medication
  • No patient contact (cancelled ambulance call or the patient was transported to the hospital before the arrival of trial-trained paramedics)
  • Received epinephrine prior to the arrival of trial-trained paramedics

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Interventions

DRUGCombination group

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)

DRUGStandard group

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


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT06203847


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