Early Albumin Resuscitation During Septic Shock - Full Text View

Sponsored by:	Laboratoire français de Fractionnement et de Biotechnologies
Information provided by:	Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier:	NCT00327704

Purpose

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	Intervention	Phase
Septic Shock	Drug: albumin Drug: saline	Phase IV

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline

Further study details as provided by Laboratoire français de Fractionnement et de Biotechnologies:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Evaluation of sequential organ failure assessment (SOFA) score [ Time Frame: ICU period ]
catecholamine free days
incidence of nosocomial infection
mortality at 90 days
length of ICU hospitalisation
length of total hospitalisation

Estimated Enrollment:	800
Study Start Date:	July 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Albumin: Active Comparator	Drug: albumin albumin 20% 100 ml/8 hours for 3 days
Saline: Placebo Comparator	Drug: saline saline 100 ml/8hours for 3 days

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327704

Contacts

Contact: Philippe Gredy, Dr

+33 1 69 82 74 49

gredy@lfb.fr

Locations

France
Cochin Hospital	Recruiting
Paris, France, 75 014
Contact: Julien Charpentier, Dr +33 1 58 41 25 36 julien.charpentier@cch.ap-hop-paris.fr
Principal Investigator: Jean P Mira, Pr

Sponsors and Collaborators

Laboratoire français de Fractionnement et de Biotechnologies

Investigators

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

More Information

Study ID Numbers:	LFB N°ALBU-0503
Study First Received:	May 17, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00327704
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:

Septic Shock

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 14, 2009