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)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients (aged \>= 18 )
• Out-of-hospital cardiac arrest in the studied regions
• Treated by paramedics authorized and capable of giving prehospital medication
Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Chiang Wen-Chu
NOT_YET_RECRUITING
Taipei City
Contact Information
Primary
WEN CHU CHIANG, PhD
drchiang.tw@gmail.com
+886 926131851
Time Frame
Start Date:2024-07-16
Estimated Completion Date:2026-12-31
Participants
Target number of participants:1274
Treatments
Experimental: Intervention group
Combined drug treatment: includes 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).~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 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.
Active_comparator: 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 minutes.