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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albumin | Drug | albumin 20% 100 ml/8 hours for 3 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality, any cause, during the 28 day period after randomization | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of sequential organ failure assessment (SOFA) score | ICU period | |
| catecholamine free days | day 28 | |
| incidence of nosocomial infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean P Mira, Professor | Cochin Hospital | Study Chair |
| Julien Charpentier, Doctor | Hôpital Cochin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Paris | Paris | 75 014 | France |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| saline | Drug | saline 100 ml/8hours for 3 days |
|
| ICU period |
| mortality at 90 days | day 90 |
| length of ICU hospitalisation | ICU discharge |
| length of total hospitalisation | hospital discharge |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |