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Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT00411879
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens

Brief Summary:
A randomized controlled trial did not show benefit of vasopressin versus epinephrine in inhospital cardiac arrest. Preceding laboratory data suggest that combined vasopressin and epinephrine ensure long-term survival and neurologic recovery. Also, postresuscitation abnormalities mimic severe sepsis. The investigators hypothesized that combined vasopressin and epinephrine during cardiopulmonary resuscitation (CPR), and steroid supplementation during and after (when required) CPR may improve survival in cardiac arrest.

Condition or disease Intervention/treatment Phase
Heart Arrest Drug: Vasopressin, Epinephrine, and Steroids Drug: Placebo, Epinephrine, Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Single-Center, Placebo-Controlled Study of the Effects of Combined Administration of Vasopressin, Methylprednisolone, and Epinephrine During Cardiopulmonary Resuscitation on Survival After Cardiac Arrest
Study Start Date : June 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007


Arm Intervention/treatment
Placebo Comparator: Control Group
Patients with refractory cardiac arrest (as defined in methods) treated according to the latest guidelines for resuscitation and receiving placebo instead of vasopressin and corticosteroids
Drug: Placebo, Epinephrine, Placebo
Epinephrine is given to both groups according to guidelines for resuscitation 2005. Control group patients receive placebo instead of vasopressin and steroids.
Experimental: Study Group
Patients with refractory cardiac arrest treated with combined vasopressin, epinephrine, and methylprednisolone during resuscitation. Patients receive stress-dose hydrocortisone for postresuscitation shock
Drug: Vasopressin, Epinephrine, and Steroids
During resuscitation, study group patients receive vasopresssin [20 IU IV maximum dose = 100 IU] and methylprednisolone (40 mg IV). Epinephrine is given to both groups according to guidelines for resuscitation 2005. In the study group, postresuscitation shock is treated with stress-dose hydrocortisone.



Primary Outcome Measures :
  1. 1) Return of Spontaneous Circulation for > 15 min and 2) Survival to discharge either to home or to a rehabilitation facility. [ Time Frame: 60 days (actual) ]

Secondary Outcome Measures :
  1. Sequential Organ Dysfunction Assessment Score during follow-up. Organ failure free days. [ Time Frame: 60 days (actual) ]
  2. Neurological status during follow-up. [ Time Frame: 60 days (actual) ]
  3. Cerebral performance during follow-up and at discharge. [ Time Frame: 60 days (actual) ]
  4. Peri-arrest arterial pressure [ Time Frame: 30 minutes (actual) ]
  5. Plasma cytokine concentration [ Time Frame: 7 days (actual) ]


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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 in-patients with cardiac arrest requiring epinephrine according to current guidelines.

Exclusion Criteria:

  • Age < 18 years.
  • Documented terminal illness (life expectancy < 6 weeks).
  • Do not resuscitate status.
  • Cardiac arrest before arrival at hospital.
  • Prior enrollment into the study (i.e. second or third inhospital arrest etc.).
  • Corticosteroid treatment before the cardiac arrest.
  • Any inaccurate documentation of CPR data such as medication, number of countershocks etc.

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): NCT00411879


Locations
Greece
Evaggelismos General Hospital
Athens, Attica, Greece, 106 75
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Spyros D Mentzelopoulos, Lecturer First Department of Intensive Care Medicine, Univerisy of Athens Medical School
Study Chair: Charis Roussos, Professor First Department of Intensive Care Medicine, Univerisy of Athens Medical School
Study Director: Spyros G Zakynthinos, As Professor First Department of Intensive Care Medicine, Univerisy of Athens Medical School

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spyros D. Mentzelopoulos, Lecturer in Intensive Care Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT00411879     History of Changes
Other Study ID Numbers: 10531-VMA
First Posted: December 15, 2006    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Heart 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
Vasoconstrictor Agents