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Clinical Trials/NCT00127907
NCT00127907CompletedPhase 4

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

Hospices Civils de Lyon2 sites in 1 country2,416 target enrollmentStarted: May 2, 2004Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
2,416
Locations
2
Primary Endpoint
Survival at hospital admission

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Survival at hospital admission

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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