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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-16

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Vasopressin, Steroid, and Epinephrine Treatment in Patients With Out-of-hospital Cardiac Arrest

NCT03317197

Cardiac Arrest

UNKNOWN PHASE4

Vasopressin, Epinephrine, and Steroids for Cardiac Arrest

NCT00729794

Cardiac Arrest

COMPLETED PHASE3

Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest

NCT00411879

Heart Arrest

COMPLETED PHASE2

Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest

NCT00127907

Cardiac Arrest

COMPLETED PHASE4

HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

NCT04591990

Postresuscitation Syndrome

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

a pragmatic randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participant: adult patients with OHCA Outcomes Assessor: in-hospital care providers (physicians, nurses...etc)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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.

Group Type EXPERIMENTAL

Combination group

Intervention Type 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)

Control 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 3-5 minutes.

Group Type ACTIVE_COMPARATOR

Standard group

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DRUG

Standard group

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No