Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest - Full Text View

Sponsor:	University of Athens
Information provided by:	University of Athens
ClinicalTrials.gov Identifier:	NCT00411879

Purpose

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	Intervention	Phase
Heart Arrest	Drug: Vasopressin, Epinephrine, and Steroids Drug: Placebo, Epinephrine, Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: CPR Cardiac Arrest

Drug Information available for: Prednisolone Epinephrine bitartrate Epinephrine Prednisolone acetate Depo-medrol Vasopressins Medrol veriderm Methylprednisolone Argipressin Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by University of Athens:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sequential Organ Dysfunction Assessment Score during follow-up. Organ failure free days. [ Time Frame: 60 days (actual) ] [ Designated as safety issue: No ]
Neurological status during follow-up. [ Time Frame: 60 days (actual) ] [ Designated as safety issue: No ]
Cerebral performance during follow-up and at discharge. [ Time Frame: 60 days (actual) ] [ Designated as safety issue: No ]
Peri-arrest arterial pressure [ Time Frame: 30 minutes (actual) ] [ Designated as safety issue: No ]
Plasma cytokine concentration [ Time Frame: 7 days (actual) ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	June 2006
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

Wenzel V, Krismer AC, Arntz HR, Sitter H, Stadlbauer KH, Lindner KH; European Resuscitation Council Vasopressor during Cardiopulmonary Resuscitation Study Group. A comparison of vasopressin and epinephrine for out-of-hospital cardiopulmonary resuscitation. N Engl J Med. 2004 Jan 8;350(2):105-13.

Stiell IG, Hebert 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Spyros D. Mentzelopoulos, University of Athens Medical School
ClinicalTrials.gov Identifier:	NCT00411879 History of Changes
Other Study ID Numbers:	10531-VMA
Study First Received:	December 14, 2006
Last Updated:	July 23, 2008
Health Authority:	Greece: Ministry of Health and Welfare

Keywords provided by University of Athens:

Heart Arrest
Cardiopulmonary Resuscitation
Epinephrine
Vasopressin
Adrenal Cortex Hormones

Additional relevant MeSH terms:

Heart Arrest
Heart Diseases
Cardiovascular Diseases
Epinephrine
Vasopressins
Arginine Vasopressin
Methylprednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
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
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012