Clinical trial

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)

Name
202204115MINA
Description
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).
Trial arms
Trial start
2024-02-01
Estimated PCD
2026-06-30
Trial end
2026-12-31
Status
Not yet recruiting
Treatment
Combination group
Combination of epinephrine (Adrenaline® 1mg/vial) every 3 minutes, vasopressin (Pitressin® 20Unints/vial) every 3 minutes up to 4 vials (a total of 80Units), methylprednisolone (Solu-Medrol® 40mg/vial)
Arms:
Intervention group
Standard group
standard doses of epinephrine (Adrenaline® 1mg/vial) every 3 minutes
Arms:
Control group
Size
1200
Primary endpoint
Rate of sustained return of spontaneous circulation (ROSC)
estimated 2 hours
Eligibility criteria
Inclusion Criteria: * Adult patients (aged \>= 18 ) * Out-of-hospital cardiac arrest in the studied regions * Treated by paramedics authorized and capable of giving prehospital medication Exclusion Criteria: * OHCA with traumatic etiology * Obvious signs of death like decapitation, rigor mortis, livor mortis, decomposition, etc. * Family members at the scene clearly expressed not to resuscitate * Patients with known or suspected pregnancy * No vascular access was established before hospital arrival * ROSC before the administrated medication * Canceled ambulance call
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a pragmatic randomized clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Participant: adult patients with OHCA Outcomes Assessor: in-hospital care providers (physicians, nurses...etc)', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1200, 'type': 'ESTIMATED'}}
Updated at
2024-01-26

1 organization

2 products

2 indications

Indication
Cardiac Arrest