Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest

October 16, 2007 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2416

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre Bénite, France, 69495
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival at hospital admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Pierre-Yves GUEUGNIAUD, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Registration Dates

First Submitted

August 5, 2005

First Submitted That Met QC Criteria

August 5, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Estimate)

October 17, 2007

Last Update Submitted That Met QC Criteria

October 16, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003.329

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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