Cardiac Arrest Clinical Trial
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).
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 1,192 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06048068 -
Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events
|
N/A | |
| Recruiting |
NCT05558228 -
Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
|
||
| Completed |
NCT03685383 -
Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation
|
N/A | |
| Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
| Completed |
NCT04619498 -
Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest
|
N/A | |
| Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
| Withdrawn |
NCT02352350 -
Lactate in Cardiac Arrest
|
N/A | |
| Completed |
NCT03024021 -
Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
|
||
| Completed |
NCT02275234 -
Care After Resuscitation
|
||
| Completed |
NCT02247947 -
Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
|
||
| Completed |
NCT01944605 -
Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest
|
N/A | |
| Completed |
NCT01972087 -
Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest
|
N/A | |
| Completed |
NCT01936597 -
Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage
|
N/A | |
| Active, not recruiting |
NCT01239420 -
Norwegian Cardio-Respiratory Arrest Study
|
||
| Completed |
NCT01191736 -
Ultra-Brief Versus Brief Hands Only CPR Video Training With and Without Psychomotor Skill Practice
|
N/A | |
| Completed |
NCT00878644 -
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
|
Phase 3 | |
| Completed |
NCT00880087 -
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
|
N/A | |
| Completed |
NCT00729794 -
Vasopressin, Epinephrine, and Steroids for Cardiac Arrest
|
Phase 3 | |
| Recruiting |
NCT00441753 -
Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest
|
N/A | |
| Completed |
NCT00347477 -
Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest
|
Phase 3 |