Status:
COMPLETED
Volume Replacement With Albumin in Severe Sepsis
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
BACKGROUND The association between mortality and hypoalbuminemia has been observed in several diseases. Nonetheless, the efficacy of albumin on survival in critically ill patients is controversial. Se...
Detailed Description
BACKGROUND AND RATIONALE The association between mortality and hypoalbuminemia has been documented in several diseases, including liver cirrhosis, nephrosic syndrome, and others. Being responsible for...
Eligibility Criteria
Inclusion
- Patients with severe sepsis or septic shock, if each one of the following criteria is satisfied:
- Proved or suspected infection in at least one site:
- lung
- abdomen
- genito-urinary tract
- other (blood, skin and soft tissue, central nervous system, bones and joints, cardiac system, catheter-related infection, other)
- Two or more of the following:
- a core temperature ≥ 38° C o ≤ 36° C
- a heart rate ≥ 90 beats/min
- a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical ventilation for an acute process
- a white blood cell count ≥ 12000/ml or ≤ 4000/ml or immature neutrophils \> 10%
- Presence of at least a severe organ dysfunction, as measured by the modified Sequential Organ Failure Assessment (SOFA) score:
- respiratory score \> 1
- hematologic score \> 1
- hepatic score \> 1
- cardiovascular score equal to 1, 3 or 4
- renal score \> 1
Exclusion
- Age below 18 years
- Terminal state
- Known adverse reaction to albumin administration
- Severe sepsis or septic shock in patients after proved or suspected head injury, clinically active
- Congestive heart failure (NYHA score III and IV)
- Pathological conditions in which albumin administration is clinically indicated (hepatic cirrhosis with ascites, intestinal malabsorption syndrome, nephritic syndrome, burns)
- More than 24 hours since inclusion criteria were met
- Religious objection to the administration of human blood products
- Inclusion in other experimental study
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
1818 Patients enrolled
Trial Details
Trial ID
NCT00707122
Start Date
July 1 2008
End Date
October 1 2013
Last Update
November 10 2015
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; Via F. Sforza 35
Milan, Italy, 20135