Early Albumin Resuscitation During Septic Shock

Phase 4

Completed

• Conditions: Septic Shock
• Interventions: Drug: saline; Drug: albumin

• Registration Number: NCT00327704
• Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

Brief 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.

Study Timeline

• Study First Submitted: 2006-05-17
• Study First Submitted QC: 2006-05-17
• Study First Posted: 2006-05-18
• Study Start: 2006-07
• Primary Completion: 2010-06
• Study Completion: 2011-01
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-05
• Last Update Posted: 2011-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 794

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	saline	-
Albumin	albumin	-

Primary Outcome Measures

Name	Time	Method
Mortality, any cause, during the 28 day period after randomization	day 28

Secondary Outcome Measures

Name	Time	Method
Evaluation of sequential organ failure assessment (SOFA) score	ICU period
catecholamine free days	day 28
incidence of nosocomial infection	ICU period
mortality at 90 days	day 90
length of ICU hospitalisation	ICU discharge
length of total hospitalisation	hospital discharge

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France