Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203847
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2023-12-18
Brief Title:
The Effect of Prehospital Combination of Epinephrine Vasopressin and Steroid in OHCA
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVIVES
Brief 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
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 ie 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 1192 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
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 ie 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 1192 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None