The Effect of Prehospital Combination of Epinephrine, Vasopressin, and Steroid in OHCA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination group, Standard group.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Emergency Medical Services. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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).
Detailed description
The global and Taiwanese survival rates for patients following an out-of-hospital cardiac arrest (OHCA) are less than 10%. The emergency medical system (EMS) plays a crucial role in patient outcomes after OHCA, providing prehospital cardiopulmonary resuscitation, defibrillation, and medication. Among these medications, the combination of epinephrine, vasopressin, and methylprednisolone holds the most potential to improve patient survival rates following OHCA.
This study aims to compare the effect of standard epinephrine therapy with a combination of epinephrine, vasopressin, and methylprednisolone administered to OHCA patients. This comparison will be made through a randomized clinical trial (RCT) within the EMS of Taipei City and New Taipei City.
Throughout the research plan, we will conduct a prehospital RCT to answer the following question (in P-I-C-O format): Will adult non-traumatic OHCA patients resuscitated by paramedics in a prehospital setting have a better chance of sustained recovery of spontaneous circulation (primary outcome), and improved survival status (secondary outcomes), if they receive combination therapy (i.e., standard doses of epinephrine, 20U of vasopressin after each dose of epinephrine up to a maximum of 80U, and one dose of 40mg methylprednisolone after the first dose of epinephrine) compared to those who receive standard doses of epinephrine? We estimate a sample size of 1,344 OHCA patients to detect a difference in the primary outcome. Based on the background data from the EMS regions under study, we expect the enrollment to take approximately 30 months to complete.
This study is referred to as the "OHCA-REVIVES" trial, which stands for A randomized clinical trial of patient outcomes following Out-of-Hospital Cardiac Arrest Receiving Epinephrine Versus In-together Vasopressin, Epinephrine, and Steroid. The anticipated results from the "OHCA-REVIVES trial" will help determine the optimal strategy for prehospital medication, and will undoubtedly have a significant impact on resuscitation science. Through these efforts, we aim to improve the outcomes of OHCA patients.
Interventions
- Drug Combination 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) - Drug Standard group
standard doses of epinephrine (Adrenaline® 1mg/vial) every 3-5 minutes
Primary outcome measures
- Rate of sustained return of spontaneous circulation (ROSC) [Time frame: estimated 2 hours]
Secondary outcome measures (3)
- Rate of prehospital return of spontaneous circulation (ROSC) [Time frame: estimated 1 hour]
- Rate of survival to hospital discharge [Time frame: estimated 30 days]
- Rate of survival with favorable neurologic status [Time frame: estimated 30 days]
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.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Publications
- Ko YC, Lin YY, Yang WS, Tseng YT, Huang TJ, Lai CT, Huang SY, Hsieh CM, Wang PL, Chen HH, Chen KY, Sun JT, Chang CH, Lu TP, Ma MH, Chiang WC. Vasopressin, steroids, and epinephrine in out-of-hospital cardiac arrest - a protocol for a randomized controlled trial (OHCA REVIVES trial). Resusc Plus. 2025 Nov 18;27:101163. doi: 10.1016/j.resplu.2025.101163. eCollection 2026 Jan. PMID 41399685
Identifiers
NCT: NCT06203847 · 202204115MINA