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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Versailles
• Collaborator: Assistance Publique - Hôpitaux de Paris
• Treatments: Dobutamine; Epinephrine; Epinephryl borate; Norepinephrine; Racepinephrine

Criteria

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 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 Criteria:

• Pregnant woman

• Obstructive cardiomyopathy

• Acute coronary disease

• Non infectious shock

• Care limitation

• White blood cell count < 500 /mm3