Current partner codePEPTIDESDE
NCT06203847·Not applicable·INTERVENTIONAL

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

Status

Recruiting

Phase

Not applicable

Enrollment

1,344

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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).

Full 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 1,344 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.

Interventions

Treatment arms and agents.

DRUG

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)

DRUG

Standard group

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

Timeline

From registration to results.

  1. First posted

    Jan 12, 2024

  2. Study start

    Jul 16, 2024

  3. Primary completion

    Jul 31, 2026

  4. Study completion

    Dec 31, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Nov 19, 2025

Outcomes

What the study measures.

Primary outcomes

Rate of sustained return of spontaneous circulation (ROSC)

Time frame · 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 outcomes

Rate of prehospital return of spontaneous circulation (ROSC)

Time frame · estimated 1 hour

presence of ROSC prior to arrival at emergency department (ED)

Rate of survival to hospital discharge

Time frame · estimated 30 days

survival to hospital admission, and without in-hospital death

Rate of survival with favorable neurologic status

Time frame · estimated 30 days

Good neurologic status (defined as Cerebral-Performance Category (CPC) score 1 and 2) at hospital discharge

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Taiwan. Showing up to 24 locations stored in the fast local snapshot.

National Taiwan University Hospital

Taipei, Taiwan

Related trials

More studies on Vasopressin.

Related PeptideStat pages

Put the record in context.

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