Septic Shock Clinical Trial
Official title:
Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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