NCT00327704

Early Albumin Resuscitation During Septic Shock

Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 794 (actual)
• Sponsor: Laboratoire français de Fractionnement et de Biotechnologies · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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, 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.

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 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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	albumin	albumin 20% 100 ml/8 hours for 3 days
DRUG	saline	saline 100 ml/8hours for 3 days

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-06-01
• Completion: 2011-01-01
• First posted: 2006-05-18
• Last updated: 2011-04-06

Locations

1 site across 1 country: France