Early Albumin Resuscitation During Septic Shock

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00327704

Enrollment

794

Registered

2006-05-18

Start date

2006-07-31

Completion date

2011-01-31

Last updated

2011-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Septic Shock

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.

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.

Interventions

DRUGalbumin

albumin 20% 100 ml/8 hours for 3 days

DRUGsaline

saline 100 ml/8hours for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Mortality, any cause, during the 28 day period after randomization	day 28

Secondary

Measure	Time frame
catecholamine free days	day 28
incidence of nosocomial infection	ICU period
Evaluation of sequential organ failure assessment (SOFA) score	ICU period
length of ICU hospitalisation	ICU discharge
length of total hospitalisation	hospital discharge
mortality at 90 days	day 90

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026