Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest - Full Text View

Sponsor:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00127907

Purpose

Recent studies have suggested that arginine-vasopressin could be more effective in the treatment of cardiac arrests. The last published study did not outline obvious improvements in the prognosis of all cardiac arrests but pointed out a possible increased survival rate when arginine-vasopressin is associated with epinephrine. The aim of this study is to compare the efficacy of two successive injections of epinephrine (1 mg) with two successive injections of epinephrine associated with arginine-vasopressin (40 UI) in out-of-hospital cardiac arrests occurring in adult patients. The primary endpoint is the survival rate at hospital admission. The inclusion period lasts 18 months and 2416 patients are planned to be enrolled.

Condition	Intervention	Phase
Cardiac Arrest	Drug: epinephrine (1 mg/1 mL) Drug: arginine-vasopressin (40 UI/2 mL)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Comparison of Epinephrine Associated With Vasopressin vs Epinephrine Alone in the Treatment of Out-of-Hospital Cardiac Arrests

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest Diabetes Insipidus

Drug Information available for: Epinephrine bitartrate Epinephrine Vasopressins Arginine Argipressin Arginine hydrochloride

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Survival at hospital admission

Secondary Outcome Measures:

ROSC (Return of spontaneous circulation) Survival at : H24, Day 28, hospital discharge and one year Neurological status at H24 and hospital discharge.

Estimated Enrollment:	2416
Study Start Date:	May 2004

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Out-of-hospital medical cardiac arrest in adult patients.

Exclusion Criteria:

Traumatic cardiac arrest
Pregnancy
Patients younger than 18 years old or older than 85 years old

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127907

Locations

France
Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Pierre-Yves GUEUGNIAUD, MD

Hospices Civils de Lyon

More Information

No publications provided by Hospices Civils de Lyon

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

Gueugniaud PY, David JS, Chanzy E, Hubert H, Dubien PY, Mauriaucourt P, Bragança C, Billères X, Clotteau-Lambert MP, Fuster P, Thiercelin D, Debaty G, Ricard-Hibon A, Roux P, Espesson C, Querellou E, Ducros L, Ecollan P, Halbout L, Savary D, Guillaumée F, Maupoint R, Capelle P, Bracq C, Dreyfus P, Nouguier P, Gache A, Meurisse C, Boulanger B, Lae C, Metzger J, Raphael V, Beruben A, Wenzel V, Guinhouya C, Vilhelm C, Marret E. Vasopressin and epinephrine vs. epinephrine alone in cardiopulmonary resuscitation. N Engl J Med. 2008 Jul 3;359(1):21-30.

ClinicalTrials.gov Identifier:	NCT00127907 History of Changes
Other Study ID Numbers:	2003.329
Study First Received:	August 5, 2005
Last Updated:	October 16, 2007
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Out-of-hospital cardiac arrest - Vasopressin - Epinephrine

Additional relevant MeSH terms:

Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Epinephrine
Arginine Vasopressin
Vasopressins
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
Hemostatics
Coagulants
Hematologic Agents
Antidiuretic Agents
Natriuretic Agents

ClinicalTrials.gov processed this record on February 12, 2012