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Completed

NCT Number: NCT00327704

Early Albumin Resuscitation During Septic Shock

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cochin Hospital

Paris, 75 014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALBUMIN

Drug

albumin 20% 100 ml/8 hours for 3 days

Other names: Vialebex

Saline

Drug

saline 100 ml/8hours for 3 days

Primary outcomes

  1. Mortality, any cause, during the 28 day period after randomization

    Time frame: day 28

Secondary outcomes

  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

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Sponsors and collaborators

Lead sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
May 18, 2006
Registry last updated
Apr 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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