Septic shock MedDRA version: 20.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: ALBUMINA GRIFOLS - 20 G/100 ML SOLUZIONE PER INFUSIONE FLACONE DA 100 ML
Pharmaceutical Form: Solution for injection
Trade Name: RINGER LATTATO S.A.L.F. - SOLUZIONE PER INFUSIONE 1 FLACON
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled if they meet the two following criteria: 1) Presence of an infection (known or suspected) in at least one site: a) Lung b) Abdomen c) Urinary tract d) Others (blood, skin and soft tissues, central nervous system, bones and joints, cardiac system, reproductive organs) 2) Presence of a severe and acute, sepsis-related cardiovascular failure, requiring vasopressor to maintain mean arterial pressure >= 65 mmHg, despite adequate volume resuscitation a) Cardiovascular SOFA score > 2 (3 or 4) Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 751 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 501
Exclusion criteria
Exclusion criteria: 1)Age < 18 years 2)Moribund state 3)Known or suspected adverse reaction to albumin administration 4)Severe sepsis or septic shock in patients with traumatic brain injury or a clinically active cerebral lesion (known or suspected) 5) Severe congestive heart failure (NYHA III and IV classes) 6) Clinical situations in which the use of albumin is known or supposed to be clinically effective (hepatic cirrhosis with ascites, malabsorption syndrome or protein-losing enteropathy, nephrotic syndrome, burns) 7) More than 24 hours after the onset of septic shock 8) Religious objection to the administration of human blood products 9) Presence of chronic end-stage renal disease 10)Severe hyperkalemia 11)Enrollment in other experimental studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the current study, in patients with septic shock, we aim to investigate whether: 1) albumin in addition to crystalloids vs crystalloids alone reduces 90-day mortality (Aim 1); 2) BAL solutions reduces 90-day mortality and/or the incidence of AKI as compared to normal saline (NS) (Aim 2). ;Secondary Objective: Aim 1 •ICU mortality •In-hospital mortality • 1-year mortality •Severity and incidence of organ failures, as assessed by the SOFA score •Incidence of AKI, as assessed by the KDIGO criteria •Use of renal replacement therapy (RRT) during ICU stay •Duration of the need for vasopressors during ICU stay •Duration of mechanical ventilation during ICU stay •Incidence of secondary-acquired infections during ICU stay •Length of stay in ICU •Length of stay in Hospital Aim 2 •90-day mortality •Incidence of AKI, as assessed by the KDIGO criteria •ICU mortality •In-hospital mortality • 1-year mortality •Severity and incidence of organ failures, as assessed by the SOFA score •Use of renal replacement therapy (RRT) during ICU stay •Incidence of severe metabolic acidosis •Incidence of severe hyperkalemia •Duration of mechanical ventilation •Length of stay in ICU •Length of stay in Hospital ;Primary end point(s): All-cause 90-day mortality (Aim 1), and a combined primary endpoint including 90-day mortality and/or incidence of AKI during the study (Aim 2).;Timepoint(s) of evaluation of this end point: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Aim 1 • ICU mortality • In-hospital mortality • Severity and incidence of organ failures, as assessed by the SOFA score • Incidence of AKI, as assessed by the KDIGO criteria • Use of renal replacement therapy (RRT) during ICU stay • Duration of the need for vasopressors during ICU stay • Duration of mechanical ventilation during ICU stay • Incidence of secondary-acquired infections during ICU stay • Length of stay in ICU • Length of stay in Hospital Aim 2 • 90-day mortality • Incidence of AKI, as assessed by the KDIGO criteria • ICU mortality • In-hospital mortality • Severity and incidence of organ failures, as assessed by the SOFA score • Use of renal replacement therapy (RRT) during ICU stay • Incidence of severe metabolic acidosis • Incidence of severe hyperkalemia • Duration of mechanical ventilation • Length of stay in ICU • Length of stay in Hospital ;Timepoint(s) of evaluation of this end point: 90 days | — |
Countries
Italy
Contacts
Public ContactDIP. DI RICERCA CARDIOVASCOLA
IRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Outcome results
None listed