Vasopressin, Epinephrine, and Steroids for Cardiac Arrest - Full Text View

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. The investigators intend to confirm or refute this hypothesis by conducting a multicenter, randomized, controlled clinical trial in inhospital cardiac arrest.

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

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, Safety/Efficacy Study

Official Title:	Vasopressin, Epinephrine, and Corticosteroids for Inhospital Cardiac Arrest: A Multicenter Randomized Controlled Trial

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 [ 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 [ Time Frame: 90 min ] [ Designated as safety issue: No ]
The number of organ failure-free days during follow-up [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Neurological status and cerebral performance during follow up and at discharge from the hospital [ 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 ]

Estimated Enrollment:	250
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Study Group: Experimental 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
Control Group: Placebo Comparator 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

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

Contacts


Contact: Spyros D Mentzelopoulos, MD, PhD	(01130)-6977465832	sdmentzelopoulos@yahoo.com

Contact: Charis Roussos, MD, PhD	(01130)-210-7243320	croussos@med.uoa.gr

Locations


Greece, Attica
	Evaggelismos General Hospital	Recruiting
	Athens, Attica, Greece, GR-10675
	Contact: Spyros D Mentzelopoulos, MD, PhD (01130)-6977465832 sdmentzelopoulos@yahoo.com
	Contact: Charis Roussos, MD, PhD (01130)-210-7243320 croussos@med.uoa.gr
	Sub-Investigator: Sotiris Malachias, MD
	Sub-Investigator: Elissavet Stamataki, MD
	Sub-Investigator: Nikos Katsios, MD
	Sub-Investigator: Anastasios Stathopoulos, MD
	Sub-Investigator: Dimitris Kostantopoulos, MD
	Sub-Investigator: Eleftherios Kostopoulos, MD
	Sub-Investigator: Andreas Lomaka, MD
	Sub-Investigator: George Hamos, MD
	Sub-Investigator: Catherine Aggeli, MD
	Sub-Investigator: Stylianos Kokkoris, MD
	401 General Military Hospital of Athens	Recruiting
	Athens, Attica, Greece, GR-11526
	Contact: Sotiris Sourlas, MD (01130)-210-7494000 ext 4502 stavrinavg@yahoo.gr
	Principal Investigator: Sotiris Sourlas, MD
	Sub-Investigator: Aloizos Stavros, MD

Greece, Thessaly
	University General Hospital of Larissa	Recruiting
	Larissa, Thessaly, Greece, GR-41110
	Contact: Epaminondas G Zakynthinos, MD (01130)-2410-681264 ezakynth@yahoo.com
	Principal Investigator: Epaminondas G Zakynthinos, MD, PhD

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, 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.

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. No abstract available.

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.

[No authors listed] 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.

Responsible Party:	University of Athens Medical School ( Spyros D. Mentzelopoulos, Lecturer; Charis Roussos, Professor )
Study ID Numbers:	VSE-226-2008
First Received:	July 31, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00729794
Health Authority:	Greece: Ministry of Health and Welfare

Keywords provided by University of Athens:

Vasopressin

Epinephrine

Adrenal Cortex Hormones

Heart Arrest

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 September 22, 2008

Sponsors and Collaborators:	University of Athens University of Thessaly
Information provided by:	University of Athens
ClinicalTrials.gov Identifier:	NCT00729794