Status:
COMPLETED
Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock
Lead Sponsor:
University of Versailles
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
Septic Shock
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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....
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...
Eligibility Criteria
Inclusion
- 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 min);
- 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
- Pregnant woman
- Obstructive cardiomyopathy
- Acute coronary disease
- Non infectious shock
- Care limitation
- White blood cell count \< 500 /mm3
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00148278
Start Date
October 1 1999
End Date
December 1 2005
Last Update
July 22 2010
Active Locations (15)
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1
Réanimation Médicale - Hôpital Louis Mourier
Colombes, France, 92700
2
Réanimation Polyvalente - Hôpital de Corbeil
Corbeil, France, 91100
3
Service de Réanimation Médicale - Hôpital Poincaré
Garches, France, 92380
4
Réanimation Médicale - Hôpital André Mignot
Le Chesnay, France, 78157