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Early Albumin Resuscitation During Septic Shock

This study has been completed.
Sponsor:
Information provided by:
Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier:
NCT00327704
First received: May 17, 2006
Last updated: April 5, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Septic Shock
 Drug: albumin
Drug: saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by Laboratoire français de Fractionnement et de Biotechnologies:

Primary Outcome Measures:
  • Mortality, any cause, during the 28 day period after randomization [ Time Frame: day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of sequential organ failure assessment (SOFA) score [ Time Frame: ICU period ] [ Designated as safety issue: No ]
  • catecholamine free days [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • incidence of nosocomial infection [ Time Frame: ICU period ] [ Designated as safety issue: No ]
  • mortality at 90 days [ Time Frame: day 90 ] [ Designated as safety issue: No ]
  • length of ICU hospitalisation [ Time Frame: ICU discharge ] [ Designated as safety issue: No ]
  • length of total hospitalisation [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 794
Study Start Date: July 2006
Study Completion Date: January 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327704

Locations
France
Cochin Hospital
Paris, France, 75 014
Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
Study Chair: Jean P Mira, Professor Cochin Hospital
Study Director: Julien Charpentier, Doctor Cochin Hospital Paris
  More Information

No publications provided

Responsible Party: Jean-Paul MIRA, Professor, Cochin Hospital, Paris France
ClinicalTrials.gov Identifier: NCT00327704     History of Changes
Other Study ID Numbers: LFB N°ALBU-0503
Study First Received: May 17, 2006
Last Updated: April 5, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
Septic Shock

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
 Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 22, 2013