MedTrace Logo

Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock

NCT00148278 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2010-07-22

No results posted yet for this study

Summary

Catecholamines infusion is a major component of septic shock management. International guidelines recommend that norepinephrine should be preferred to epinephrine, though phase III trials are lacking. The present study aimed at comparing the efficacy and safety of norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.

Conditions

Interventions

DRUG

norepinephrine and dobutamine

continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 70mmHg or more and dobutamine could be added as a continuous infusion when cardiac index was of less than 2.5 liters per squared meter of body surface

DRUG

epinephrine plus placebo of dobutamine

epinephrine was titrated to maintain a mean arterial pressure at 70mmHg or more and placebo of dobutamine was titrated in case of a cardiac index lower than 2.5 liters per squared meters of body surface

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • University of Versailles

    lead OTHER

Principal Investigators

  • Djillali Annane, MD, PhD · Assistance Publique Hôpitaux de Paris - University of Versailles

  • Eric Bellissant, MD, PhD · CHU Rennes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2004-12-31
Completion
2005-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00148278 on ClinicalTrials.gov