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

NCT06203847 | Recruiting DMC

• 1 other identifier: 202204115MINA
• Study Type: interventional
• Target: 1,344
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Arrest; Out-Of-Hospital Cardiac Arrest; Emergency Medical Services

Keywords

Out-Of-Hospital Cardiac Arrest; Emergency Medical Services; Corticosteroid; Epinephrine; Vasopressin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of prehospital return of spontaneous circulation (ROSC)

  estimated 1 hour

• Rate of survival to hospital discharge

  estimated 30 days

• Rate of survival with favorable neurologic status

  estimated 30 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Combined drug treatment: includes 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). 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 3-5 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.

Drug: Combination group

Control group

ACTIVE COMPARATOR

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 3-5 minutes.

Drug: Standard group

Interventions

Combination group DRUG

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)

Intervention group

Standard group DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• WEN CHU CHIANG, Phd

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WEN CHU CHIANG, PhD

CONTACT

+886 926131851; drchiang.tw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant: adult patients with OHCA Outcomes Assessor: in-hospital care providers (physicians, nurses...etc)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a pragmatic randomized clinical trial

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 12, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon completion of the study, estimated at the end of 2026, the sharing of Individual Participant Data (IPD) will be made available following local privacy protection laws.
• Access Criteria: reasonable request to the corresponding authors.

Locations

TW (1)