Early Albumin Resuscitation During Septic Shock

LFB

Status and phase: Completed; Phase 4

Conditions: Septic Shock

Treatments: Drug: saline; Drug: albumin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327704

LFB N°ALBU-0503

Details and patient eligibility

About

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.

Enrollment: 794 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years old
• Septic shock < 6 hours
• Agreement of patients

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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794 participants in 2 patient groups, including a placebo group

Albumin

Active Comparator group

Treatment:

Drug: albumin

Saline

Placebo Comparator group

Treatment:

Drug: saline