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

This study has been completed.
Sponsor:
Collaborator:
University of Thessaly
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens
ClinicalTrials.gov Identifier:
NCT00729794
First received: July 31, 2008
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • The number of organ failure-free days during follow-up [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Complications related to the use of steroids [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

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
Study First Received: July 31, 2008
Last Updated: May 3, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by University of Athens:
Vasopressin
Epinephrine
Adrenal Cortex Hormones
Heart Arrest

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Epinephrine
Epinephryl borate
Vasopressins
Arginine Vasopressin
Methylprednisolone
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Methylprednisolone acetate
Prednisolone acetate
Hydrocortisone
Methylprednisolone Hemisuccinate
 Prednisolone
Hydrocortisone-17-butyrate
Prednisolone hemisuccinate
Prednisolone phosphate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on May 23, 2013