Early Albumin Resuscitation During Septic Shock

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EstadoTerminado

Patrocinadores

Laboratoire français de Fractionnement et de Biotechnologies

ENSAYO CLÍNICO: NCT00327704

BioSeek: nct00327704

Palabras clave

Abstracto

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.

Descripción

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.

fechas

Verificado por última vez:	03/31/2011
Primero enviado:	05/16/2006
Inscripción estimada enviada:	05/16/2006
Publicado por primera vez:	05/17/2006
Última actualización enviada:	04/04/2011
Última actualización publicada:	04/05/2011
Fecha de inicio real del estudio:	06/30/2006
Fecha estimada de finalización primaria:	05/31/2010
Fecha estimada de finalización del estudio:	12/31/2010

Condición o enfermedad

Septic Shock

Intervención / tratamiento

Drug: Albumin

Drug: Saline

Fase

Fase 4

Grupos de brazos

Brazo	Intervención / tratamiento
Active Comparator: Albumin	Drug: Albumin albumin 20% 100 ml/8 hours for 3 days
Placebo Comparator: Saline	Drug: Saline saline 100 ml/8hours for 3 days

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	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

Salir

Medidas de resultado primarias

1. Mortality, any cause, during the 28 day period after randomization [day 28]

Medidas de resultado secundarias

1. Evaluation of sequential organ failure assessment (SOFA) score [ICU period]

2. catecholamine free days [day 28]

3. incidence of nosocomial infection [ICU period]

4. mortality at 90 days [day 90]

5. length of ICU hospitalisation [ICU discharge]

6. length of total hospitalisation [hospital discharge]