Patients with severe sepsis or septic shock MedDRA version: 9.1 Level: SOC Classification code 10021881 Term: Infections and infestations
Conditions
Interventions
Product Name: Albumin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Albumin
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 60-
Sponsors
OSPEDALE MAGGIORE DI MILANO (IRCCS)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify the hypothesis that volume replacement with albumin and its maintenance within predefined plasmatic physiologic range (equal to or greater than 30 g/l) improves survival of patients with severe sepsis or septic shock, as compared to a volume replacement with the use of crystalloids. Survival will be measured until the 28th and 90th day after enrollment.;Secondary Objective: To verify the hypothesis that volume replacement with albumin and its maintenance within predefined plasmatic physiologic range (equal to or greater than 30 g/l) reduces: 1. The numbers and the severity of organ dysfunction, as detected by the SOFA score 2. ICU length of stay 3. The Hospital length of stay;Primary end point(s): Absolute risk reduction of overall mortality of 7.5% at the 28th, with a further control at 90th day, after randomization | — |
Countries
Italy
Outcome results
None listed