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Vasopressin, Epinephrine, and Steroids for Cardiac Arrest (VSE-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729794
First Posted: August 8, 2008
Last Update Posted: November 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Thessaly
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens
  Purpose
The simultaneous activation of adrenergic and vasopressin receptors, in conjunction with a potential steroid-mediated enhancement of the vascular reactivity to epinephrine may have beneficial effects in patients with cardiac arrest. This hypothesis is supported by the single-center results of NCT 00411879. The investigators intend to either refute or provide definitive evidence supporting this hypothesis (and its generalizability) by conducting the present multicenter, randomized, controlled clinical trial of in hospital cardiac arrest.

Condition Intervention Phase
Cardiac Arrest Drug: Vasopressin, Epinephrine, Methylprednisolone, Hydrocortisone Drug: Standard CPR Protocol with Epinephrine and two Placebos Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vasopressin, Epinephrine, and Corticosteroids for Inhospital Cardiac Arrest: A Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Spyros D. Mentzelopoulos, University of Athens:

Primary Outcome Measures:
  • Return of Spontaneous Circulation for at least 15 min and Survival to Hospital Discharge with or without neurological recovery [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • Arterial pressure and gas exchange during CPR and at 15-20 min following return of spontaneous circulation; hemodynamic status during days 1 to 10 post-randomization [ Time Frame: 30 min to 10 days ]
  • The number of organ failure-free days during follow-up [ Time Frame: 60 days ]
  • Complications related to the use of steroids [ Time Frame: 10 days ]

Enrollment: 300
Study Start Date: September 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
Patients with refractory, inhospital cardiac arrest, i.e., with asystole, pulseless electrical activity, or ventricular fibrillation/pulseless ventricular tachycardia not responsive to two attempts at defibrillation.
Drug: Vasopressin, Epinephrine, Methylprednisolone, Hydrocortisone

Combination Treatment

Administration of vasopressin, epinephrine, and methylprednisolone during CPR, and of stress dose hydrocortisone after CPR

Placebo Comparator: Control Group
Patients with refractory, inhospital cardiac arrest, i.e., with asystole, pulseless electrical activity, or ventricular fibrillation/pulseless ventricular tachycardia not responsive to two attempts at defibrillation.
Drug: Standard CPR Protocol with Epinephrine and two Placebos
Patients receive advanced life support according to the Guidelines for Resuscitation 2005

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with refractory inhospital cardiac arrest, defined as epinephrine requirement for ventricular fibrillation/tachycardia or asystole/pulseless electrical activity according to guidelines for resuscitation 2005 (5).

Exclusion Criteria:

  • Age < 18 years
  • Terminal illness or do-not resuscitate status
  • Cardiac arrest due to exsanguination
  • Cardiac arrest before hospital admission
  • Pre-arrest treatment with intravenous corticosteroids
  • Previous enrollment in or exclusion from the current study
  Contacts and Locations
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): NCT00729794


Locations
Greece
Evaggelismos General Hospital
Athens, Attica, Greece, GR-10675
401 General Military Hospital of Athens
Athens, Attica, Greece, GR-11526
University General Hospital of Larissa
Larissa, Thessaly, Greece, GR-41110
Sponsors and Collaborators
University of Athens
University of Thessaly
Investigators
Principal Investigator: Spyros D Mentzelopoulos, MD, PhD University of Athens Medical School, Athens, Greece
Study Director: Spyros G Zakynthinos, MD, PhD University of Athens Medical School, Athens, Greece
Study Chair: Charis Roussos, MD, PhD University of Athens Medical School, Athens, Greece
  More Information

Publications:
Sandroni C, Nolan J, Cavallaro F, Antonelli M. In-hospital cardiac arrest: incidence, prognosis and possible measures to improve survival. Intensive Care Med. 2007 Feb;33(2):237-45. Epub 2006 Sep 22. Review.
Stiell IG, Hébert PC, Wells GA, Vandemheen KL, Tang AS, Higginson LA, Dreyer JF, Clement C, Battram E, Watpool I, Mason S, Klassen T, Weitzman BN. Vasopressin versus epinephrine for inhospital cardiac arrest: a randomised controlled trial. Lancet. 2001 Jul 14;358(9276):105-9.
Adrie C, Laurent I, Monchi M, Cariou A, Dhainaou JF, Spaulding C. Postresuscitation disease after cardiac arrest: a sepsis-like syndrome? Curr Opin Crit Care. 2004 Jun;10(3):208-12. Review.
Hékimian G, Baugnon T, Thuong M, Monchi M, Dabbane H, Jaby D, Rhaoui A, Laurent I, Moret G, Fraisse F, Adrie C. Cortisol levels and adrenal reserve after successful cardiac arrest resuscitation. Shock. 2004 Aug;22(2):116-9.
Nolan JP, Deakin CD, Soar J, Böttiger 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. Review.
Shizukuda Y, Miura T, Ishimoto R, Itoya M, Iimura O. Effect of prednisolone on myocardial infarct healing: characteristics and comparison with indomethacin. Can J Cardiol. 1991 Dec;7(10):447-54.
A randomized clinical trial of calcium entry blocker administration to comatose survivors of cardiac arrest. Design, methods, and patient characteristics. The Brain Resuscitation Clinical Trial II Study Group. Control Clin Trials. 1991 Aug;12(4):525-45.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spyros D. Mentzelopoulos, Assistant Professor in Intensive Care Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT00729794     History of Changes
Other Study ID Numbers: VSE-226-2008
First Submitted: July 31, 2008
First Posted: August 8, 2008
Last Update Posted: November 21, 2016
Last Verified: November 2016

Keywords provided by Spyros D. Mentzelopoulos, University of Athens:
Vasopressin
Epinephrine
Adrenal Cortex Hormones
Heart Arrest

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Vasopressins
Arginine Vasopressin
Prednisolone acetate
Methylprednisolone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Hydrocortisone
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


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