Early Albumin Resuscitation During Septic Shock
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00327704|
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : April 6, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: albumin Drug: saline||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||794 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||January 2011|
|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
- Mortality, any cause, during the 28 day period after randomization [ Time Frame: day 28 ]
- Evaluation of sequential organ failure assessment (SOFA) score [ Time Frame: ICU period ]
- catecholamine free days [ Time Frame: day 28 ]
- incidence of nosocomial infection [ Time Frame: ICU period ]
- mortality at 90 days [ Time Frame: day 90 ]
- length of ICU hospitalisation [ Time Frame: ICU discharge ]
- length of total hospitalisation [ Time Frame: hospital discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327704
|Paris, France, 75 014|
|Study Chair:||Jean P Mira, Professor||Cochin Hospital, India|
|Study Director:||Julien Charpentier, Doctor||Cochin Hospital Paris|