Early Albumin Resuscitation During Septic Shock
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline|
- Mortality, any cause, during the 28 day period after randomization [ Time Frame: day 28 ] [ Designated as safety issue: No ]
- Evaluation of sequential organ failure assessment (SOFA) score [ Time Frame: ICU period ] [ Designated as safety issue: No ]
- catecholamine free days [ Time Frame: day 28 ] [ Designated as safety issue: No ]
- incidence of nosocomial infection [ Time Frame: ICU period ] [ Designated as safety issue: No ]
- mortality at 90 days [ Time Frame: day 90 ] [ Designated as safety issue: No ]
- length of ICU hospitalisation [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]
- length of total hospitalisation [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||January 2011|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Albumin||
albumin 20% 100 ml/8 hours for 3 days
Other Name: Vialebex
|Placebo Comparator: Saline||
saline 100 ml/8hours for 3 days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327704
|Paris, France, 75 014|
|Study Chair:||Jean P Mira, Professor||Cochin Hospital|
|Study Director:||Julien Charpentier, Doctor||Cochin Hospital Paris|