Early Albumin Resuscitation During Septic Shock

Study Overview
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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.

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.

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

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: albumin
* Drug: saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Albumin<br> | Drug: albumin<br>* albumin 20% 100 ml/8 hours for 3 days<br>* Other names: Vialebex;|
| Placebo Comparator: Saline<br> | Drug: saline<br>* saline 100 ml/8hours for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality, any cause, during the 28 day period after randomization |  | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septic Shock