Cardiac ArrestREVIVESNCT06203847
The Effect of Prehospital Combination of Epinephrine, Vasopressin, and Steroid in OHCA
A study testing Combination group and Standard group in people with Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Emergency Medical Services
- What is being tested?
- Combination group and Standard group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,344 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged >= 18 )
- Out-of-hospital cardiac arrest in the studied regions
- Treated by paramedics authorized and capable of giving prehospital medication
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wen-Chu Chiang, MD, PhD, 886-2-23123456, drchiang.tw@gmail.com
About this study
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)
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).
Read the 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.
- Being tested
- Combination group, Standard group
- Keywords
- Out-Of-Hospital Cardiac Arrest, Emergency Medical Services, Corticosteroid, Epinephrine, Vasopressin
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination groupDrug
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)
Standard groupDrug
standard doses of epinephrine (Adrenaline® 1mg/vial) every 3-5 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: estimated 2 hours
Secondary outcomes (3)
Rate of prehospital return of spontaneous circulation (ROSC)
presence of ROSC prior to arrival at emergency department (ED)
Measured: estimated 1 hour
Rate of survival to hospital discharge
survival to hospital admission, and without in-hospital death
Measured: estimated 30 days
Rate of survival with favorable neurologic status
Good neurologic status (defined as Cerebral-Performance Category (CPC) score 1 and 2) at hospital discharge
Measured: estimated 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start16 Jul 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- a pragmatic randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WEN CHU CHIANG, Phd, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203847
- Sponsor's protocol ID
- 202204115MINA
- Acronym
- REVIVES
- Status last verified
- Nov 2025
- First submitted
- 18 Dec 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study, the sharing of Individual Participant Data (IPD) will be made available in accordance with local privacy protection laws.
Publications
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.
PubMed 41399685
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06203847
- Acronym / sponsor ID
- REVIVES / 202204115MINA
- Keywords
- Out-Of-Hospital Cardiac Arrest, Emergency Medical Services, Corticosteroid, Epinephrine, Vasopressin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,344 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1,344 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- a pragmatic randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Combination groupCombined 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. |
| Control group | Active comparator | Drug: Standard groupStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (aged >= 18 )
- Out-of-hospital cardiac arrest in the studied regions
- Treated by paramedics authorized and capable of giving prehospital medication
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination groupCombination 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 | Intervention group |
| Standard groupstandard doses of epinephrine (Adrenaline® 1mg/vial) every 3-5 minutes | Drug | Control group |
Primary outcome
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).
3 secondary outcomes
Rate of prehospital return of spontaneous circulation (ROSC)
Time frame: estimated 1 hour
Rate of survival to hospital discharge
Time frame: estimated 30 days
Rate of survival with favorable neurologic status
Time frame: estimated 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 41399685Ko 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.
- Individual participant dataSharing planned: Yes. Upon completion of the study, the sharing of Individual Participant Data (IPD) will be made available in accordance with local privacy protection laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
WEN CHU CHIANG, Phd principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination group and Standard group in people with Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WEN CHU CHIANG, PhD (+886 926131851, drchiang.tw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sustained return of spontaneous circulation (ROSC) (time frame: estimated 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06203847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.