Efficacy of albumin administration for volume replacement in patients with severe sepsis or septic shock - Volume replacement with albumin in severe sepsis

• Conditions: Patients with severe sepsis or septic shock; MedDRA version: 9.1Level: SOCClassification code 10021881Term: Infections and infestations

• Registration Number: EUCTR2008-003281-25-IT
• Lead Sponsor: OSPEDALE MAGGIORE DI MILANO (IRCCS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with severe sepsis or septic shock, if each one of the following criteria is satisfied:
1)Proved or suspected infection in at least one site:
a)lung
b)abdomen
c)genito-urinary tract
d)other (blood, skin and soft tissue, central nervous system, bones and joints, cardiac system, catheter-related infection, other)

2)Two or more of the following:
a)a core temperature ≥ 38 C o ≤ 36 C;
b)a heart rate ≥ 90 beats/min;
c)a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical ventilation for an acute process;
d)a white blood cell count ≥ 12000/ml or ≤ 4000/ml or immature neutrophils > 10%.

3)Presence of at least a severe organ dysfunction, as measured by the modified Sequential Organ Failure Assessment (SOFA) score:
a)respiratory score > 1;
b)hematologic score > 1;
c)hepatic score > 1;
d)cardiovascular score equal to 1, 3 or 4;
e)renal score > 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Age below 18 years
2)Terminal state
3)Known adverse reaction to albumin administration
4)Severe sepsis or septic shock in patients after proved or suspected head injury, clinically active
5)Congestive heart failure (NYHA score III and IV)
6)Pathological conditions in which albumin administration is clinically indicated (hepatic cirrhosis with ascites, intestinal malabsorption syndrome, nephritic syndrome, burns)
7)More than 24 hours since inclusion criteria were met
8)Religious objection to the administration of human blood products
9)Inclusion in other experimental study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified