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

Официальное название

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)

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Rate of sustained return of spontaneous circulation (ROSC) [Срок оценки: estimated 2 hours]

Вторичные конечные точки (3)

• Rate of prehospital return of spontaneous circulation (ROSC) [Срок оценки: estimated 1 hour]
• Rate of survival to hospital discharge [Срок оценки: estimated 30 days]
• Rate of survival with favorable neurologic status [Срок оценки: estimated 30 days]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Публикации

• 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

Идентификаторы

NCT: NCT06203847 · 202204115MINA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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