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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, randomized, controlled versus saline, stratified on nosocomial infection and center.
Setting: 27 Intensive Care Units (ICU) in France
Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris
Patients: 800 patients could be included during the first 6 hours of their septic shock.
Full 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 of hospitalisation, incidence of nosocomial infections.
The albuminemia of all patients is requested before the treatment until Day 4 post treatment.
The treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days.
The first patient will be in July 2006, the last patient expected is on July 2009.
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794 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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