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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
794
Cochin Hospital
Paris, Paris, France
Mortality, any cause, during the 28 day period after randomization
Time frame: day 28
Evaluation of sequential organ failure assessment (SOFA) score
Time frame: ICU period
catecholamine free days
Time frame: day 28
incidence of nosocomial infection
Time frame: ICU period
mortality at 90 days
Time frame: day 90
length of ICU hospitalisation
Time frame: ICU discharge
length of total hospitalisation
Time frame: hospital discharge
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