Early Albumin Resuscitation During Septic Shock

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT00327704
Lead Sponsor: Laboratoire français de Fractionnement et de BiotechnologiesINDUSTRY
Overall Status: Completed
Study Type: Interventional
Phase: Phase 4
Enrollment: 794Actual
Last Update Posted: Apr 6, 2011Estimated
Start Date: Jul 2006
Primary Completion Date: Jun 2010Actual
Completion Date: Jan 2011Actual

What the study is about and why it is being run, in the researchers' own words.

Official Title: Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline
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.
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 medical conditions and diseases this study investigates.

The treatments and procedures being evaluated in this study.

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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

How the study is designed and how its participant groups are organized.

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Where the study is run and whether each site is currently recruiting.

Cochin Hospital

Paris, Paris 75 014, France

The organizations and people involved in this study.

Lead Sponsor: Laboratoire français de Fractionnement et de BiotechnologiesINDUSTRY

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