DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: University of Versailles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock; Severe Sepsis; Infections

Intervention: norepinephrine and dobutamine (Drug); epinephrine plus placebo of dobutamine (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Versailles

Official(s) and/or principal investigator(s):
Djillali Annane, MD, PhD, Study Director, Affiliation: Assistance Publique Hôpitaux de Paris - University of Versailles
Eric Bellissant, MD, PhD, Study Chair, Affiliation: CHU Rennes


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.

Clinical Details

Official title: Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 28 Day mortality

Secondary outcome:

-28-day survival distribution

-Survival rate at days 14, 28, 90, 6 months and 1 year.

-Rate of patients with secondary care limitation

-Organ failure between randomization and day 28.

-Serious adverse events between randomization and exit of intensive care unit.

-Onset of a reversible clinical event between randomization and exit of intensive care unit (bronchospasm, cutaneous rash, tachycardia)

-Time on vasopressors

-Time in intensive care unit

-Time in hospital


Detailed description: The french Conference on Consensus on catecholamines use in septic shock has underlined the importance of carrying out a clinical trial to clarify the use of epinephrine, norepinephrine and dobutamine in the management of multiple organ failure associated with severe sepsis. The main objective of the study was therefore to compare the effects of the combination of dobutamine and norepinephrine to those of epinephrine alone in patients with septic shock. In this purpose, patients were randomly assigned to receive either epinephrine or norepinephrine plus dobutamine and drugs were titrated to maintain blood pressure over 70 mmHg. Main outcome was 28-day mortality.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adults over 18 years

- Informed consent

Presenting from less than 7 days :

- One or more infectious site

- At least 2 of the following criteria: temperature > 38°C or < 36. 5°C, respiratory

rate > 20 breaths per min or PaCO2 < 32 mmHg or mechanical ventilation, heart rate > 90 beats/min, white blood cell count > 12,000/mm3 or < 4,000/mm3

- At least 2 of the following criteria: PaO2/FiO2 ratio <280 mmHg (if mechanical

ventilation, urinary output of less than 0. 5 mL/kg of body weight or < 30 mL/h at least 1 hour, plasma lactate > 2 mmol/L, platelet count < 100,000 /mm3 And presenting from at least 24 hours:

- Systolic blood pressure < 90 mmHg or mean blood pressure < 70 mmHg (for at least 30


- 1000 mL fluid replacement or pulmonary capillary wedge pressure > 12 mmHg

- Dopamine infusion at 15 µg/kg/min for at least 1 hour, or epinephrine or

norepinephrine in first intention Exclusion Criteria:

- Pregnant woman

- Obstructive cardiomyopathy

- Acute coronary disease

- Non infectious shock

- Care limitation

- White blood cell count < 500 /mm3

Locations and Contacts

Réanimation Médicale - Hôpital Louis Mourier, Colombes 92700, France

Réanimation Polyvalente - Hôpital de Corbeil, Corbeil 91100, France

Service de Réanimation Médicale - Hôpital Poincaré, Garches 92380, France

Réanimation Médicale - Hôpital André Mignot, Le Chesnay 78157, France

Réanimation Polyvalente - Hôpital Dupuytren, Limoges 87000, France

Réanimation Polyvalente - Hôpital Nord, Marseille 13009, France

Réanimation Chirurgicale - Hôpital Central, Nancy 54035, France

Service de Réanimation Médicale - Hôpital Central, Nancy 54035, France

Réanimation Médicale - Hôpital Georges Pompidou, Paris 75908, France

Réanimation Médicale - Hôpital Saint Louis, Paris 75010, France

Réanimation Polyvalente - Hôpital Saint Joseph, Paris 75014, France

Service d'anesthésiologie - HIA Val de Grâce, Paris 75005, France

Réanimation Médicale - CHI de Poissy, Poissy 78303, France

Réanimation - CH Victor Provo, Roubaix 59100, France

Réanimation Polyvalente - Institut Gustave Roussy, Villejuif 94800, France

Additional Information

Starting date: October 1999
Last updated: July 21, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017