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Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
epinephrine (1 mg/1 mL)
arginine-vasopressin (40 UI/2 mL)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Out-of-hospital cardiac arrest - Vasopressin - Epinephrine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Lyon Sud

Outcomes

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.

Full Information

First Posted
August 5, 2005
Last Updated
October 16, 2007
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00127907
Brief Title
Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest
Official Title
Comparison of Epinephrine Associated With Vasopressin vs Epinephrine Alone in the Treatment of Out-of-Hospital Cardiac Arrests
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Out-of-hospital cardiac arrest - Vasopressin - Epinephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2416 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
epinephrine (1 mg/1 mL)
Intervention Type
Drug
Intervention Name(s)
arginine-vasopressin (40 UI/2 mL)
Primary Outcome Measure Information:
Title
Survival at hospital admission
Secondary Outcome Measure Information:
Title
ROSC (Return of spontaneous circulation) Survival at : H24, Day 28, hospital discharge and one year Neurological status at H24 and hospital discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves GUEUGNIAUD, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18596271
Citation
Gueugniaud PY, David JS, Chanzy E, Hubert H, Dubien PY, Mauriaucourt P, Braganca C, Billeres 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, Guillaumee 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. doi: 10.1056/NEJMoa0706873.
Results Reference
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Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest

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