Early Albumin Resuscitation During Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

794 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albumin

Group Type ACTIVE_COMPARATOR

albumin

Intervention Type DRUG

albumin 20% 100 ml/8 hours for 3 days

Saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

saline 100 ml/8hours for 3 days

Interventions

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albumin

albumin 20% 100 ml/8 hours for 3 days

Intervention Type DRUG

saline

saline 100 ml/8hours for 3 days

Intervention Type DRUG

Other Intervention Names

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Vialebex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No