Status:
COMPLETED
Dopexamine and Norepinephrine Compared With Epinephrine Alone in Septic Shock
Lead Sponsor:
Rennes University Hospital
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In septic shock, when volume resuscitation fails to restore mean arterial pressure, catecholamines such as dopamine, dobutamine, epinephrine, or norepinephrine are used, either alone or in combination...
Detailed Description
Objective: To compare the combination of dopexamine and norepinephrine with epinephrine alone on gastric mucosal blood flow (GMBF), hepatic damage and oxidative stress in septic shock. Setting: Surgi...
Eligibility Criteria
Inclusion
- Adults over 18 years
- Informed consent
- Septic shock with:
- evidence of infection;
- at least 3 of the following criteria: temperature \> 38°C or \< 36.5°C; respiratory rate \> 20 breaths per minute 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: plasma lactate \> 2 mmol/L or unexplained metabolic acidosis (pH \< 7.3); hypoxemia defined by PaO2 \< 70 mmHg at room air or a PaO2/FiO2 ratio \< 280 mmHg (or \< 200 mmHg if pneumonia was the source of sepsis) or need for mechanical ventilation; urine output \< 30 mL/h for at least 2 hours despite a fluid challenge of at least 500mL; a platelet count \< 100,000/mm3, a decrease of 50% from previous value, or unexplained coagulopathy (prothrombin time \< 60% and elevated fibrin degradation products \> 10 μg/mL);
- systolic blood pressure \< 90 mmHg despite an optimal volume loading defined by a pulmonary capillary wedge pressure \> 12 mmHg.
Exclusion
- Pregnant women
- Patients with a history of esophageal or gastric disease
- Patients with a history of esophageal or gastric surgery
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00134212
Start Date
March 1 2002
End Date
June 1 2004
Last Update
January 2 2006
Active Locations (1)
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1
Rennes University Hospital
Rennes, France, 35033