Clinical trial NCT06203847: The Effect of Prehospital Combination of Epinephrine, Vasopressin, and Steroid in OHCA
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Out-Of-Hospital Cardiac Arrest
Emergency Medical Services
Keywords: Out-Of-Hospital Cardiac Arrest
Emergency Medical Services
Corticosteroid
Epinephrine
Vasopressin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a pragmatic randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of sustained return of spontaneous circulation (ROSC)
timeFrame: estimated 2 hours
Secondary outcomes:
measure: Rate of prehospital return of spontaneous circulation (ROSC)
timeFrame: estimated 1 hour
measure: Rate of survival to hospital discharge
timeFrame: estimated 30 days
measure: Rate of survival with favorable neurologic status
timeFrame: estimated 30 days
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Chiang Wen-Chu
state: Taipei
Study officials:
affiliation: National Taiwan University Hospital
name: WEN CHU CHIANG, Phd
role: PRINCIPAL_INVESTIGATOR
References: