Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00327704
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
2006-05-17
Brief Title:
Early Albumin Resuscitation During Septic Shock
Sponsor:
Laboratoire français de Fractionnement et de Biotechnologies
Organization:
Laboratoire français de Fractionnement et de Biotechnologies
Study Overview
Official Title:
Multicenter Prospective Randomized Controlled Open Study Albumin 20 Versus Saline
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 JP Mira and Dr J Charpentier - Cochin Hospital- Paris
Patients 800 patients could be included during the first 6 hours of their septic shock
Design Prospective multicenter randomized controlled versus saline stratified on nosocomial infection and center
Setting 27 Intensive Care Units ICU in France
Coordinator Pr JP 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None