Early Albumin Resuscitation During Septic Shock
Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline
1 other identifier
interventional
794
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2006
CompletedFirst Posted
Study publicly available on registry
May 18, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedApril 6, 2011
April 1, 2011
3.9 years
May 17, 2006
April 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality, any cause, during the 28 day period after randomization
day 28
Secondary Outcomes (6)
Evaluation of sequential organ failure assessment (SOFA) score
ICU period
catecholamine free days
day 28
incidence of nosocomial infection
ICU period
mortality at 90 days
day 90
length of ICU hospitalisation
ICU discharge
- +1 more secondary outcomes
Study Arms (2)
Albumin
ACTIVE COMPARATORSaline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Over 18 years old
- Septic shock \< 6 hours
- Agreement of patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cochin Hospital
Paris, Paris, 75 014, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean P Mira, Professor
Cochin Hospital
- STUDY DIRECTOR
Julien Charpentier, Doctor
Hôpital Cochin
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 17, 2006
First Posted
May 18, 2006
Study Start
July 1, 2006
Primary Completion
June 1, 2010
Study Completion
January 1, 2011
Last Updated
April 6, 2011
Record last verified: 2011-04