Early Albumin Resuscitation During Septic Shock
Palabras clave
Abstracto
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
Intervención / tratamiento
Drug: Albumin
Drug: Saline
Fase
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]