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Early Albumin Resuscitation During Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00327704
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : April 6, 2011
Sponsor:
Information provided by:
Laboratoire français de Fractionnement et de Biotechnologies

Study Description
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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.


Condition or disease Intervention/treatment Phase
Septic Shock Drug: albumin Drug: saline Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 794 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline
Study Start Date : July 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Albumin Drug: albumin
albumin 20% 100 ml/8 hours for 3 days
Other Name: Vialebex
Placebo Comparator: Saline Drug: saline
saline 100 ml/8hours for 3 days


Outcome Measures
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Primary Outcome Measures :
  1. Mortality, any cause, during the 28 day period after randomization [ Time Frame: day 28 ]

Secondary Outcome Measures :
  1. Evaluation of sequential organ failure assessment (SOFA) score [ Time Frame: ICU period ]
  2. catecholamine free days [ Time Frame: day 28 ]
  3. incidence of nosocomial infection [ Time Frame: ICU period ]
  4. mortality at 90 days [ Time Frame: day 90 ]
  5. length of ICU hospitalisation [ Time Frame: ICU discharge ]
  6. length of total hospitalisation [ Time Frame: hospital discharge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327704


Locations
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France
Cochin Hospital
Paris, France, 75 014
Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
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Study Chair: Jean P Mira, Professor Cochin Hospital
Study Director: Julien Charpentier, Doctor Hôpital Cochin
More Information
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Responsible Party: Jean-Paul MIRA, Professor, Cochin Hospital, Paris France
ClinicalTrials.gov Identifier: NCT00327704    
Other Study ID Numbers: LFB N°ALBU-0503
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: April 2011
Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
Septic Shock
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
 Infections
Systemic Inflammatory Response Syndrome
Inflammation