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

Cardiac Arrest Clinical Trial

— REVIVES  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06203847
• Other study ID #: 202204115MINA
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: WEN CHU CHIANG, PhD
• Phone: +886 926131851
• Email: drchiang.tw[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Emergencies
• Emergency Medical Services
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Drug:
• 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)
• Standard group
standard doses of epinephrine (Adrenaline® 1mg/vial) every 3 minutes

Locations

Country	Name	City	State
Taiwan	Chiang Wen-Chu	Taipei city	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of sustained return of spontaneous circulation (ROSC)	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).	estimated 2 hours
Secondary	Rate of prehospital return of spontaneous circulation (ROSC)	presence of ROSC prior to arrival at emergency department (ED)	estimated 1 hour
Secondary	Rate of survival to hospital discharge	survival to hospital admission, and without in-hospital death	estimated 30 days
Secondary	Rate of survival with favorable neurologic status	Good neurologic status (defined as Cerebral-Performance Category (CPC) score 1 and 2) at hospital discharge	estimated 30 days