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

NCT03317197 | Unknown Phase 4

• 1 other identifier: KUGH17156 (VSE study)
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Out-of-Hospital Cardiac Arrest; Vasopressin-steroid-epinephrine (VSE); Treatment Outcome; prognosis; Return of spontaneous circulation

Outcome Measures

Primary Outcomes (1)

• Examined for neurological prognosis of each group

  \- main result variables: survival discharge with good CPC (CPC 1 or 2)

  survival discharge, through study completion, an average of 1 year

Secondary Outcomes (1)

• Examined for return of spontaneous circulation (ROSC) status

  ROSC, up to 24 hours

Study Arms (4)

Control Group

PLACEBO COMPARATOR

* 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

Experimental Group 1

ACTIVE COMPARATOR

* 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

Experimental Group 2

ACTIVE COMPARATOR

* 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

Experimental Group 3

EXPERIMENTAL

* 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

Interventions

Control Group DRUG

Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) only

Also known as: Epinephrine

Control Group

Experimental Group 1 DRUG

Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) and Vasopressin(20 international unit(IU)/cardiopulmonary resuscitation(CPR) cycle)

Also known as: Epinephrine + Vasopressin

Experimental Group 1

Experimental Group 2 DRUG

Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) and Steroid(Methylprednisolone, 40 mg at first cycle)

Also known as: Epinephrine + Steroid

Experimental Group 2

Experimental Group 3 DRUG

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)

Also known as: Epinephrine + Vasopressin + Steroid

Experimental Group 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

RECRUITING

Related Publications (8)

• Mentzelopoulos SD, Zakynthinos SG, Tzoufi M, Katsios N, Papastylianou A, Gkisioti S, Stathopoulos A, Kollintza A, Stamataki E, Roussos C. Vasopressin, epinephrine, and corticosteroids for in-hospital cardiac arrest. Arch Intern Med. 2009 Jan 12;169(1):15-24. doi: 10.1001/archinternmed.2008.509.

  PMID: 19139319 BACKGROUND

• Nolan JP, Deakin CD, Soar J, Bottiger BW, Smith G; European Resuscitation Council. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation. 2005 Dec;67 Suppl 1:S39-86. doi: 10.1016/j.resuscitation.2005.10.009. No abstract available.

  PMID: 16321716 BACKGROUND

• Mentzelopoulos SD, Malachias S, Chamos C, Konstantopoulos D, Ntaidou T, Papastylianou A, Kolliantzaki I, Theodoridi M, Ischaki H, Makris D, Zakynthinos E, Zintzaras E, Sourlas S, Aloizos S, Zakynthinos SG. Vasopressin, steroids, and epinephrine and neurologically favorable survival after in-hospital cardiac arrest: a randomized clinical trial. JAMA. 2013 Jul 17;310(3):270-9. doi: 10.1001/jama.2013.7832.

  PMID: 23860985 BACKGROUND

• Mentzelopoulos SD, Mongardon N, Xanthos T, Zakynthinos SG. Possible significance of hemodynamic and immunomodulatory effects of early stress-dose steroids in cardiac arrest. Crit Care. 2016 Jul 20;20(1):211. doi: 10.1186/s13054-016-1384-4. No abstract available.

  PMID: 27436285 BACKGROUND

• Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center's Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3;20:82. doi: 10.1186/s13054-016-1257-x.

  PMID: 27038920 BACKGROUND

• Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.

  PMID: 26472995 BACKGROUND

• Kim JJ, Lim YS, Shin JH, Yang HJ, Kim JK, Hyun SY, Rhoo I, Hwang SY, Lee G. Relative adrenal insufficiency after cardiac arrest: impact on postresuscitation disease outcome. Am J Emerg Med. 2006 Oct;24(6):684-8. doi: 10.1016/j.ajem.2006.02.017.

  PMID: 16984836 BACKGROUND

• Kim JY, Shin SD, Ro YS, Song KJ, Lee EJ, Park CB, Hwang SS; CardioVascular Disease Surveillance (CAVAS) investigators. Post-resuscitation care and outcomes of out-of-hospital cardiac arrest: a nationwide propensity score-matching analysis. Resuscitation. 2013 Aug;84(8):1068-77. doi: 10.1016/j.resuscitation.2013.02.010. Epub 2013 Feb 27.

  PMID: 23454438 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Interventions

Control Groups; Epinephrine; Vasopressins; Steroids

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jung-Youn Kim, MD, Ph.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Youn Kim, MD, Ph.D.

CONTACT

82-2-2626-3285; yellowwizard@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 23, 2017
• Study Start: January 1, 2018
• Primary Completion: August 9, 2020
• Study Completion: August 9, 2020
• Last Updated: October 23, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)