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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014