Effect of Vasopressin, Steroid, and Epinephrine Treatment in Patients With Out-of-hospital Cardiac Arrest
|ClinicalTrials.gov Identifier: NCT03317197|
Recruitment Status : Unknown
Verified October 2017 by Jung-Youn Kim, Korea University Guro Hospital.
Recruitment status was: Recruiting
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Drug: Control Group Drug: Experimental Group 1 Drug: Experimental Group 2 Drug: Experimental Group 3||Phase 4|
In South Korea, approximately 20,000 patients are found to experience cardiac arrest (CA) annually, with a reported survival rate of approximately 4.8% (2015). In patients who are resuscitated from cardiac arrest (CA), neurological prognosis is assessed based on whether the patient can independently perform a daily routine after leaving the hospital. It is an essential issue for patients, as well as their families and local communities. In this sense, research interest in achieving a good neurological prognosis in post-discharge cardiac arrest (CA) patients is increasing. The neurologic status of post-cardiac arrest (CA) patients, who are being considered for discharge from the hospital, is examined mostly using the Cerebral Performance Category (CPC) score, with a score of 1 or 2, on a scale of 1 to 5, indicative of good neurological status.
Several previous South Korean studies have compared treatments using epinephrine only with those using epinephrine, vasopressin, and steroid during cardiopulmonary resuscitation (CPR) of cardiac arrest (CA)patients in the hospital. The vasopressin-steroid-epinephrine (VSE) group was reported to show a better return of spontaneous circulation (ROSC), lower whole-body inflammatory reaction, less cases of organ failure, and more cases of survival and hospital leave while showing better results of neurological prognosis. However, studies are lacking on treatment of cardiac arrest (CA) cases outside the hospital. In addition, because the three drugs of the vasopressin-steroid-epinephrine (VSE) regimen are used together, it is hard to identify which of them is most effective. Investigators are implementing a multicenter, prospective study to compare the use of vasopressin, steroid, and both vasopressin and steroid in post-cardiac arrest (CA) patients outside the hospital and examine the effects on ROSC and neurological score in this population.
No South Korean study has been conducted on additional drugs of injection, other than epinephrine, in cardiac arrest (CA) treatment. In one study, steroid use in post-cardiac arrest (CA) patients with return of spontaneous circulation (ROSC) was investigated by examining the levels of blood cortisol and adrenal corticotropic hormone. The researchers found that patients showing relatively poorer results in the exams recorded lower. Therefore, steroid use could be considered for patients with weaker adrenal function among those with post-cardiac arrest (CA) return of spontaneous circulation (ROSC), according to the study.
This finding is consistent with the medical background of this present study. It is possible that steroid use not only assists the adrenal function in post-cardiac arrest (CA) patients but also positively influences their spontaneous circulation recovery and neurological prognosis. However, this research is also the result of a single-organizational retrospective study. To establish additional corresponding experiences, a multicenter prospective investigation is deemed necessary.
As previously mentioned, several studies involving in-hospital cardiac arrest (CA) patients have been conducted. The present study will be the first to investigate these additional drugs of injection and associated prognosis in cardiac arrest (CA) patients outside the hospital, providing significant basic data.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||834 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Comparison of the Effect of Vasopressin, Steroid, and Epinephrine Treatment in Patients With Out-of-hospital Cardiac Arrest: Multi-center, Double Blind, Randomized, Placebo-controlled Study|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||August 9, 2020|
|Estimated Study Completion Date :||August 9, 2020|
Placebo Comparator: Control Group
Drug: Control Group
Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) only
Other Name: Epinephrine
Active Comparator: Experimental Group 1
Drug: Experimental Group 1
Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) and Vasopressin(20 international unit(IU)/cardiopulmonary resuscitation(CPR) cycle)
Other Name: Epinephrine + Vasopressin
Active Comparator: Experimental Group 2
Drug: Experimental Group 2
Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) and Steroid(Methylprednisolone, 40 mg at first cycle)
Other Name: Epinephrine + Steroid
Experimental: Experimental Group 3
Drug: Experimental Group 3
Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle), Vasopressin(20 international unit(IU)/cardiopulmonary resuscitation(CPR) cycle) and Steroid(Methylprednisolone, 40 mg at first cycle)
Other Name: Epinephrine + Vasopressin + Steroid
- Examined for neurological prognosis of each group [ Time Frame: survival discharge, through study completion, an average of 1 year ]- main result variables: survival discharge with good CPC (CPC 1 or 2)
- Examined for return of spontaneous circulation (ROSC) status [ Time Frame: ROSC, up to 24 hours ]sustained ROSC (more than 20mins)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317197
|Contact: Jung-Youn Kim, MD, Ph.D.||email@example.com|
|Korea, Republic of|
|Korea University Guro Hospital||Recruiting|
|Seoul, Guro-gu, Korea, Republic of, 08308|
|Contact: Seung-hoe Song, MBE 82-2-2626-1635 firstname.lastname@example.org|
|Principal Investigator:||Jung-Youn Kim, MD, Ph.D.||Assistant Professor|