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NCT00127907 Clinical Trial

Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:
Comparison of Epinephrine Associated With Vasopressin vs Epinephrine Alone in the Treatment of Out-of-Hospital Cardiac Arrests

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00127907
Other study ID # 2003.329
Secondary ID
Status Completed
Phase Phase 4
First received August 5, 2005
Last updated October 16, 2007
Start date May 2004

Study information
Verified date October 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2416
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• epinephrine (1 mg/1 mL)

• arginine-vasopressin (40 UI/2 mL)

Locations
Country Name City State
France Centre Hospitalier Lyon Sud Pierre Bénite

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival at hospital admission
Secondary ROSC (Return of spontaneous circulation) Survival at : H24, Day 28, hospital discharge and one year Neurological status at H24 and hospital discharge.
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