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

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

MedlinePlus related topics:

CPR

ChemIDplus related topics:

Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Methylprednisolone Corticosteroids Epinephrine Epinephrine bitartrate Argipressin Vasopressins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

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
Control Group: Placebo Comparator 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.
Study Group: Experimental 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.

Show Detailed Description

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, Attica
	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.

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

Keywords provided by University of Athens:

Heart Arrest

Cardiopulmonary Resuscitation

Epinephrine

Vasopressin

Adrenal Cortex Hormones

Study placed in the following topic categories:

Heart Diseases

Hydrocortisone

Cortisol succinate

Methylprednisolone

Methylprednisolone acetate

Heart Arrest

Prednisolone acetate

Arginine Vasopressin

Prednisolone

Vasopressins

Hydrocortisone acetate

Epinephrine

Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Coagulants

Antineoplastic Agents

Physiological Effects of Drugs

Hematologic Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Hormones

Neuroprotective Agents

Adrenergic Agonists

Therapeutic Uses

Vasoconstrictor Agents

Cardiovascular Diseases

Adrenergic alpha-Agonists

Antineoplastic Agents, Hormonal

Adrenergic beta-Agonists

Sympathomimetics

Gastrointestinal Agents

Anti-Asthmatic Agents

Cardiovascular Agents

Glucocorticoids

Protective Agents

Pharmacologic Actions

Hemostatics

Mydriatics

Autonomic Agents

ClinicalTrials.gov processed this record on October 15, 2008

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