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    Summary
    EudraCT Number:2018-001582-16
    Sponsor's Protocol Code Number:RF-2016-02361583
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001582-16
    A.3Full title of the trial
    Efficacy of Albumin Replacement and Balanced Crystalloid Solutions in Septic Shock (the ALBIOSS-BALANCED trial): a 2-by-2 factorial, investigator-initiated, open-label, multicenter, randomized, controlled trial.
    Efficacy of Albumin Replacement and Balanced Crystalloid Solutions in Septic Shock (the ALBIOSS-BALANCED trial): a 2-by-2 factorial, investigator-initiated, open-label, multicenter, randomized, controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A large 2-by-2 factorial randomized clinical trial testing the efficacy of albumin and the low-chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol – BAL) in septic shock.
    Studio multicentrico randomizzato su albumina e soluzioni bilanciate in pazienti con shock settico
    A.3.2Name or abbreviated title of the trial where available
    ALBIOSS-BALANCED
    ALBIOSS-BALANCED
    A.4.1Sponsor's protocol code numberRF-2016-02361583
    A.5.4Other Identifiers
    Name:ALBIOSS-BALANCEDNumber:RF-2016-02361583
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMINISTERO DELLA SALUTE BANDO 2016
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.5.2Functional name of contact pointDIP. DI RICERCA CARDIOVASCOLA
    B.5.3 Address:
    B.5.3.1Street AddressVIA LA MASA, 19
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0239014454
    B.5.5Fax number0233200049
    B.5.6E-mailroberto.latinii@marionegri.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ALBUMINA GRIFOLS - 20 G/100 ML SOLUZIONE PER INFUSIONE FLACONE DA 100 ML
    D.2.1.1.2Name of the Marketing Authorisation holderINSTITUTO GRIFOLS S.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name RINGER LATTATO S.A.L.F. - SOLUZIONE PER INFUSIONE 1 FLACONCINO 500 ML
    D.2.1.1.2Name of the Marketing Authorisation holderS.A.L.F. SPA LABORATORIO FARMACOLOGICO
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name RINGER ACETATO LDB - SOLUZIONE PER INFUSIONE FLACONCINO 500 ML
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORI DIACO BIOMEDICALI S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CRYSTALSOL - SOLUZIONE PER INFUSIONE 20 SACCHE IN PO/PA DA 500 ML
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Septic shock
    Shock settico
    E.1.1.1Medical condition in easily understood language
    Septic shock
    Shock settico
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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).
    Nel presente studio, in pazienti con shock settico, ci proponiamo di studiare se: 1) la somministrazione di albumina in aggiunta a cristalloidi, rispetto all’utilizzo dei soli cristalloidi riduce la mortalità a 90 giorni (Obiettivo 1); l’utilizzo di soluzioni cristalloidi bilanciate (BAL) riduce la mortalità a 90 giorni o l’incidenza di insufficienza renale acuta, rispetto all’utilizzo di Soluzione Fisiologica (NS) (Obiettivo 2).
    E.2.2Secondary objectives of the trial
    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
    Obiettivo 1
    • Mortalità in Terapia Intensiva
    • Mortalità intra-ospedaliera
    • Mortalità a 1 anno
    • Gravità e incidenza di insufficienze d’organo, valutate con SOFA
    • Incidenza di insufficienza renale acuta, valutata secondo i criteri KDIGO
    • Uso di tecniche di depurazione renale durante degenza in Terapia Intensiva
    • Durata della necessità di farmaci vasopressori durante degenza in Terapia Intensiva
    • Durata della ventilazione meccanica durante degenza in Terapia Intensiva
    • Incidenza di infezioni secondarie acquisite, durante degenza in Terapia Intensiva
    • Durata della degenza in Terapia Intensiva
    • Durata della degenza ospedaliera
    Obiettivo 2
    • Mortalità a 90 giorni
    • Incidenza di insufficienza renale acuta, valutata secondo i criteri KDIGO
    • Mortalità in Terapia Intensiva
    • Mortalità intra-ospedaliera
    • Mortalità a 1 anno
    • Gravità e incidenza di insufficienze d’organo, valutate con SOFA
    • Uso di tecniche di depurazione renale durante degenza in Ti
    • Durata ospedalizzazione
    E.2.3Trial contains a sub-study No
    E.3Principal 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)
    1) Presenza di una certa o sospetta infezione in almeno una
    sede:
    a) Polmone
    b) Addome
    c) Trattogenito-urinario
    d) Altro (sangue, tessuti molli, sistema nervoso centrale,
    apparato osteoarticolare, sistema cardiaco, organi
    riproduttivi)
    2) Presenza di una grave ed acuta insufficienza cardiovascolare sepsi-correlata, necessitante l’utilizzo di farmaci vasopressori per mantenere una pressione arteriosa media>= 65 mmHg, nonostante un adeguato rimpiazzo volemico.
    a) Punteggio cardiovascolare SOFA > 2 (3 o 4)
    E.4Principal 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
    1) Età inferiore ai 18 anni
    2) Stato terminale
    3) Reazione allergica nota o sospetta alla somministrazione di albumina
    4) Shock settico in pazienti con trauma cerebrale o lesione cerebrale nota o sospetta, clinicamente attiva
    5) Severa Insufficienza cardiaca congestizia (classe NYHA III e IV)
    6) Situazioni cliniche in cui l’utilizzo di albumina è di provata o supposta efficacia clinica (cirrosi epatica ascitogena, sindrome da malassorbimento o da proteino-dispersione intestinale, sindrome nefrosica, ustioni estese)
    7) Passate più di 24 ore dall’insorgenza dello shock settico
    8) Obiezione religiosa alla somministrazione di emocomponenti umani
    9) Presenza di insufficienza renale cronica terminale
    10) Grave iperkalemia
    11) Inclusione in altri studi sperimentali
    E.5 End points
    E.5.1Primary 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).
    Mortalità per ogni causa a 90 giorni (Obiettivo 1), e la combinazione di mortalità per ogni causa a 90 giorni e/o l’incidenza di insufficienza renale acuta durante lo studio (Obiettivo 2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days
    90 giorni
    E.5.2Secondary 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
    Obiettivo 1
    • Mortalità in Terapia Intensiva
    • Mortalità intra-ospedaliera
    • Gravità e incidenza di insufficienze d’organo, valutate con il punteggio SOFA
    • Incidenza di insufficienza renale acuta, valutata secondo i criteri KDIGO
    • Uso di tecniche di depurazione renale durante degenza in Terapia Intensiva
    • Durata della necessità di farmaci vasopressori durante degenza in Terapia Intensiva
    • Durata della ventilazione meccanica durante degenza in Terapia Intensiva
    • Incidenza di infezioni secondarie acquisite, durante degenza in Terapia Intensiva
    • Durata della degenza in Terapia Intensiva
    • Durata della degenza ospedaliera
    Obiettivo 2
    • Mortalità a 90 giorni
    • Incidenza di insufficienza renale acuta, valutata secondo i criteri KDIGO
    • Mortalità in Terapia Intensiva
    • Mortalità intra-ospedaliera
    • Gravità e incidenza di insufficienze d’organo, valutate con il punteggio SOFA
    • Uso di tecniche di depurazione renale durante degenza in Terapia Intensiva
    • Incidenza di grave acidosi metabolica
    • Incidenza d grave iperkalemia
    • Durata della ventilazione meccanica durante degenza in Terapia Intensiva
    • Durata della degenza in Terapia Intensiva
    • Durata della degenza ospedaliera
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days
    90 giorni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    • Ringer Lattato
    • Ringer Acetato
    • Crystalsol
    • Normal Saline (Na+ 154 mEq/L, Cl– 154 mEq/L)
    • Ringer Lactate
    • Ringer Acetate
    • Crystalsol
    • Normal Saline (Na+ 154 mEq/L, Cl– 154 mEq/L)
    E.8.2.4Number of treatment arms in the trial4
    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.8.4.1Number of sites anticipated in Member State concerned42
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 751
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 501
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients addmitted in septic shock may not be able to fully understand the informations to the patient and give their informed consent. In all these cases information delivery will be postponed
    La maggior parte dei pazienti in shock settico non sarà in grado di comprendere le informazioni fornite e di dare il proprio consenso primo di iniziare i trattamenti in studio In questi casi le informazioni verrano fornite ai pazienti successivamente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state0
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients after the end of the trial will be treated according to Clinical Guidelines.
    I pazienti alla fine della sperimentazione verranno trattati secondo le linee guida cliniche.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-08
    P. End of Trial
    P.End of Trial StatusOngoing
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