E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with severe sepsis or septic shock |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10021881 |
E.1.2 | Term | Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: bioumorale
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E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 150 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |