Early Albumin Resuscitation During Septic Shock

April 5, 2011 updated by: Laboratoire français de Fractionnement et de Biotechnologies

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

794

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75 014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality, any cause, during the 28 day period after randomization
Time Frame: day 28
day 28

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (Estimate)

May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LFB N°ALBU-0503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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