Early Albumin Resuscitation During Septic Shock

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LFB

Status and phase

Completed
Phase 4

Conditions

Septic Shock

Treatments

Drug: saline
Drug: albumin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327704
LFB N°ALBU-0503

Details and patient eligibility

About

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.

Full 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.

Enrollment

794 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

794 participants in 2 patient groups, including a placebo group

Albumin
Active Comparator group
Treatment:
Drug: albumin
Saline
Placebo Comparator group
Treatment:
Drug: saline

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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