Early Albumin Resuscitation During Septic Shock

Sponsor

Laboratoire français de Fractionnement et de Biotechnologies (Industry)

Overall Status

Completed

CT.gov ID

NCT00327704

Collaborator

(none)

794

Enrollment

Location

Arms

Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

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 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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

794 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Albumin	Drug: albumin albumin 20% 100 ml/8 hours for 3 days Other Names: Vialebex
Placebo Comparator: Saline	Drug: saline saline 100 ml/8hours for 3 days

Arm

Intervention/Treatment

Active Comparator: Albumin

Drug: albumin

albumin 20% 100 ml/8 hours for 3 days

Other Names:

Vialebex

Placebo Comparator: Saline

Drug: saline

saline 100 ml/8hours for 3 days

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of sequential organ failure assessment (SOFA) score [ICU period]
catecholamine free days [day 28]
incidence of nosocomial infection [ICU period]
mortality at 90 days [day 90]
length of ICU hospitalisation [ICU discharge]
length of total hospitalisation [hospital discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cochin Hospital	Paris		France	75 014

Sponsors and Collaborators

Laboratoire français de Fractionnement et de Biotechnologies

Investigators

Study Chair: Jean P Mira, Professor, Cochin Hospital
Study Director: Julien Charpentier, Doctor, Hôpital Cochin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00327704

Other Study ID Numbers:

LFB N°ALBU-0503

First Posted:

May 18, 2006

Last Update Posted:

Apr 6, 2011

Last Verified:

Apr 1, 2011

Keywords provided by , ,

Septic Shock

Additional relevant MeSH terms:

Shock, Septic

Shock

Study Results

No Results Posted as of Apr 6, 2011