The Effect of Prehospital Combination of Epinephrine, Vasopressin, and Steroid in OHCA
- Conditions
- Cardiac ArrestOut-Of-Hospital Cardiac ArrestEmergency Medical Services
- Interventions
- Drug: Combination groupDrug: Standard group
- Registration Number
- NCT06203847
- Lead Sponsor
- National Taiwan University Hospital
- Brief 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).
- 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 1,192 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- Adult patients (aged >= 18 )
- Out-of-hospital cardiac arrest in the studied regions
- Treated by paramedics authorized and capable of giving prehospital medication
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Combination group Combined drug treatment: includes 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). The method of administration is as follows: after the first administration of epinephrine (Adrenaline® 1mg/vial) to patients with cardiac arrest before hospital arrival, vasopressin (Pitressin® 20Unints/vial) and methylprednisolone (Solu-Medrol® 40mg/vial) are given simultaneously; thereafter, every 3 minutes, 1 mg (1 dose) of (Adrenaline® 1mg/vial) is given, along with 20 Units (1 dose) of vasopressin (Pitressin® 20Unints/vial) up to a maximum of 4 doses (a total of 80 Units) of vasopressin can be given before hospital arrival. Control group Standard group Standard drug treatment: epinephrine (Adrenaline® 1mg/vial). According to international resuscitation guidelines ( Advanced Cardiac Life Support, ACLS), patients with cardiac arrest before hospital arrival are given 1 mg (1 dose) of epinephrine (Adrenaline® 1mg/vial) every 3 minutes.
- Primary Outcome Measures
Name Time Method Rate of sustained return of spontaneous circulation (ROSC) estimated 2 hours 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).
- Secondary Outcome Measures
Name Time Method Rate of prehospital return of spontaneous circulation (ROSC) estimated 1 hour presence of ROSC prior to arrival at emergency department (ED)
Rate of survival to hospital discharge estimated 30 days survival to hospital admission, and without in-hospital death
Rate of survival with favorable neurologic status estimated 30 days Good neurologic status (defined as Cerebral-Performance Category (CPC) score 1 and 2) at hospital discharge
Trial Locations
- Locations (1)
Chiang Wen-Chu
🇨🇳Taipei city, Taipei, Taiwan