Status:
COMPLETED
Early Albumin Resuscitation During Septic Shock
Lead Sponsor:
Laboratoire français de Fractionnement et de Biotechnologies
Conditions:
Septic Shock
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients. Design: Prospective, multicenter, ...
Detailed Description
The primary outcome: Mortality during the 28 day period after randomization. The secondary outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine free days, days o...
Eligibility Criteria
Inclusion
- Over 18 years old
- Septic shock \< 6 hours
- Agreement of patients
Exclusion
- Allergy to albumin
- Weight \> 120 kg
- Non septic shock
- Burned
- Cirrhosis
- Albumin perfusion 48 hours before randomization
- Pregnant women
- Cardiac dysfunction New York Heart Association (NYHA) 3 or 4
- Patients with therapeutic limitation
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
794 Patients enrolled
Trial Details
Trial ID
NCT00327704
Start Date
July 1 2006
End Date
January 1 2011
Last Update
April 6 2011
Active Locations (1)
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1
Cochin Hospital
Paris, Paris, France, 75 014