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Effect of Vasopressin, Steroid, and Epinephrine Treatment in Patients With Out-of-hospital Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT03317197
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Jung-Youn Kim, Korea University Guro Hospital

Brief Summary:
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 former study. This finding is consistent with the medical background of this present study. This 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.

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Placebo Comparator: Control Group
  • Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) only
  • Control group receives intravenous injection of 1 mg epinephrine every cycle (about 3 minutes) during CPR and uses syringe No. 1, 5 times (every 3 minutes), and syringe No. 2, one time (in the first cycle). After each injection, inject 10 mL saline solution additionally.

    • Syringe No. 1 : Saline solution
    • Syringe No. 2 : Saline solution
Drug: Control Group
Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) only
Other Name: Epinephrine

Active Comparator: Experimental Group 1
  • Using Vasopressin [20 IU/CPR cycle] injection until the 5th cycle
  • Experimental Group 1 receives intravenous injection of 1 mg epinephrine every cycle (about 3 minutes) during CPR and uses syringe No. 1, 5 times (every 3 minutes), and syringe No. 2, one time (in the first cycle). After each injection, inject 10 mL saline solution additionally.

    • Syringe No. 1 : Vasopressin
    • Syringe No. 2 : Saline solution
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
  • Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) and Steroid(Methylprednisolone, 40 mg at first cycle)
  • Experimental Group 2 receives intravenous injection of 1 mg epinephrine every cycle (about 3 minutes) during CPR and uses syringe No. 1, 5 times (every 3 minutes), and syringe No. 2, one time (in the first cycle). After each injection, inject 10 mL saline solution additionally.

    • Syringe No. 1 : Saline solution
    • Syringe No. 2 : Steroid
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
  • 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)
  • Experimental Group 3 receives intravenous injection of 1 mg epinephrine every cycle (about 3 minutes) during CPR and uses syringe No. 1, 5 times (every 3 minutes), and syringe No. 2, one time (in the first cycle). After each injection, inject 10 mL saline solution additionally.

    • Syringe No. 1 : Vasopressin
    • Syringe No. 2 : Steroid
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Examined for return of spontaneous circulation (ROSC) status [ Time Frame: ROSC, up to 24 hours ]
    sustained ROSC (more than 20mins)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The group of patients who participated in the study included adults aged at least 19 years among the atraumatic CA outpatients who came to the ER and received CPR.

Exclusion Criteria:

  • Pregnant women and young children aged <18 years;
  • Patients with underlying disease cases without the possibility of resuscitation (e.g., terminal cancer);
  • Patients with do-not-resuscitate (DNR) status;
  • Death by excessive bleeding (e.g., abdominal main artery rupture);
  • Patients who have experienced in-hospital CA;
  • Patients previously treated with steroid, anti-cancer medicine, or immunosuppression treatment before CA;
  • Patients already been registered with other studies; or
  • Patients from whom informed consent cannot be obtained

Information from the National Library of Medicine

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


Contacts
Contact: Jung-Youn Kim, MD, Ph.D. 82-2-2626-3285 yellowwizard@hanmail.net

Locations
Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Guro-gu, Korea, Republic of, 08308
Contact: Seung-hoe Song, MBE    82-2-2626-1635    ssessong@korea.ac.kr   
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
Principal Investigator: Jung-Youn Kim, MD, Ph.D. Assistant Professor

Publications:

Responsible Party: Jung-Youn Kim, Assistant Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03317197     History of Changes
Other Study ID Numbers: KUGH17156 (VSE study)
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jung-Youn Kim, Korea University Guro Hospital:
Out-of-Hospital Cardiac Arrest
Vasopressin-steroid-epinephrine (VSE)
Treatment Outcome
prognosis
Return of spontaneous circulation

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Vasopressins
Arginine Vasopressin
Methylprednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics