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    Summary
    EudraCT Number:2018-000404-42
    Sponsor's Protocol Code Number:RH-ITA-007
    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:2020-05-08
    Trial results View 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 number2018-000404-42
    A.3Full title of the trial
    Effects of restricting intravenous fluids vs. standard care fluid therapy in patients with septic shock
    The Conservative vs. Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) Trial
    Effetti della restrizione fluidica vs terapia standard in pazienti con shock settico: approccio conservativo vs liberale alla terapia fluidica dello shock settico in terapia intensiva (CLASSIC) Trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Conservative vs. Liberal Approach to fluid therapy of Septic Shock in Intensive Care.
    L'approccio conservativo contro liberale alla fluidoterapia nello shock settico in terapia intensiva.
    A.3.2Name or abbreviated title of the trial where available
    CLASSIC
    CLASSIC
    A.4.1Sponsor's protocol code numberRH-ITA-007
    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 SponsorDept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet
    B.1.3.4CountryDenmark
    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 supportFondazione Novo Nordisk
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto Clinico Humanitas
    B.5.2Functional name of contact pointDipartimento Anestesia e Terapia In
    B.5.3 Address:
    B.5.3.1Street AddressVia Alessandro Manzoni 56
    B.5.3.2Town/ cityRozzano (MI)
    B.5.3.3Post code20089
    B.5.3.4CountryItaly
    B.5.6E-mailmaurizio.cecconi@hunimed.eu
    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.2.1.2Country 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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVEICOLO ACQUOSO ALLO 0,9% DI CLORURO DI SODIO
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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: 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.2.1.2Country 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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIO CLORURO/POTASSIO CLORURO/CALCIO CLORURO/SODIO ACETATO
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameRINGER'S ACETATE SOLUTION
    D.3.9.4EV Substance CodeSUB190935
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.2.1.2Country 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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIO LATTATO/SODIO CLORURO/POTASSIO CLORURO/CALCIO CLORURO BIIDRATO
    D.3.9.1CAS number 8026-79-7
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameRINGER'S LACTATE SOLUTION
    D.3.9.4EV Substance CodeSUB33298
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.2.1.2Country 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.3.1Product nameCrystalsol
    D.3.2Product code na
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIO CL./POTASSIO CL./MAGNESIO CL. ESAIDRATO/SODIO ACETATO TRIIDRATO/SODIO GLUCONATO
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive namePLASMALYTE-A
    D.3.9.4EV Substance CodeSUB118335
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Sepsis with severe circulatory failure
    Sepsi con grave insufficienza circolatoria
    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
    Obiettivo di questo studio è la valutazione dei benefici e dei rischi della restrizione fluidica endovenosa rispetto alla terapia standard su outcomes clinicamente rilevanti (quali mortalità a 90 giorni) in pazienti adulti con shock settico ricoverati in terapia intensiva.
    Obiettivo di questo studio è la valutazione dei benefici e dei rischi della restrizione fluidica endovenosa rispetto alla terapia standard su outcomes clinicamente rilevanti (quali mortalità a 90 giorni) in pazienti adulti con shock settico ricoverati in terapia intensiva.
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Età maggiore d 18 anni
    Ammesso all'ICU o in procinto di essere ammesso alla ICU indipendentemente dalla partecipazione allo studio
    Shock settico definito secondo i criteri Sepsi-3 [9]:
    Sito di infezione sospetto o confermato o emocoltura positiva E
    infusione di vasopressore / agente inotropo in corso per mantenere una pressione arteriosa media di 65 mmHg o superiore E
    Lattato di 2 mmol / L o superiore in qualsiasi campione di plasma eseguito nelle ultime 3 ore
    Aver ricevuto almeno 1 L dei 4 fluidi (cristalloidi, colloidi o prodotti sanguigni) nelle ultime 24 ore prima dello screening.
    Età maggiore d 18 anni
    Ammesso all'ICU o in procinto di essere ammesso alla ICU indipendentemente dalla partecipazione allo studio
    Shock settico definito secondo i criteri Sepsi-3 [9]:
    Sito di infezione sospetto o confermato o emocoltura positiva E
    infusione di vasopressore / agente inotropo in corso per mantenere una pressione arteriosa media di 65 mmHg o superiore E
    Lattato di 2 mmol / L o superiore in qualsiasi campione di plasma eseguito nelle ultime 3 ore
    Aver ricevuto almeno 1 L dei 4 fluidi (cristalloidi, colloidi o prodotti sanguigni) nelle ultime 24 ore prima dello screening.
    E.4Principal exclusion criteria
    - Shock settico per più di 12 ore al momento dello screening perché vogliamo includere i pazienti all'inizio del loro percorso
    - Emorragia potenzialmente letale poiché questi pazienti necessitano di strategie specifiche per i fluidi / emoderivati
    - Una lesione acuta da ustioni di oltre il 10% della superficie corporea in quanto questi pazienti necessitano di una strategia specifica per i fluidi
    - Gravidanza nota (dettagli presentati nell'appendice 2)
    - Consenso non ottenibile secondo il modello approvato per il sito specifico.
    - Shock settico per più di 12 ore al momento dello screening perché vogliamo includere i pazienti all'inizio del loro percorso
    - Emorragia potenzialmente letale poiché questi pazienti necessitano di strategie specifiche per i fluidi / emoderivati
    - Una lesione acuta da ustioni di oltre il 10% della superficie corporea in quanto questi pazienti necessitano di una strategia specifica per i fluidi
    - Gravidanza nota (dettagli presentati nell'appendice 2)
    - Consenso non ottenibile secondo il modello approvato per il sito specifico.
    E.5 End points
    E.5.1Primary end point(s)
    Mortalità per tutte le cause al giorno 90 dopo la randomizzazione
    Mortalità per tutte le cause al giorno 90 dopo la randomizzazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    Giorno 90 dopo la randomizzazione
    Giorno 90 dopo la randomizzazione
    E.5.2Secondary end point(s)
    - Numero di partecipanti con uno o più eventi avversi gravi (SAE) in ICU definiti come eventi ischemici (ischemia cerebrale, cardiaca, intestinale o degli arti) o come nuovo episodio di danno renale acuto grave (modificato KDIGO3)
    - Numero di partecipanti con una o più reazioni avverse gravi (SAR) ai IV cristalloidi in ICU.
    - 90 giorni di sopravvivenza senza supporto vitale (vasopressore / supporto
    inotropico, ventilazione meccanica invasiva o terapia sostitutiva renale)
    - 90 giorni di sopravvivenza dopo la dimissione dall'ospedale
    - Mortalità per tutte le cause a 1 anno dopo la randomizzazione
    - HRQoL 1 anno dopo la randomizzazione misurata utilizzando i punteggi EuroQoL (EQ)-5D-5L e EQ-VAS. Ai partecipanti che sono morti verranno assegnati i punteggi più bassi possibili
    - Funzione cognitiva 1 anno dopo la randomizzazione come valutata dal punteggio di valutazione cognitiva di Montreal (MoCa)
    - Numero di partecipanti con uno o più eventi avversi gravi (SAE) in ICU definiti come eventi ischemici (ischemia cerebrale, cardiaca, intestinale o degli arti) o come nuovo episodio di danno renale acuto grave (modificato KDIGO3)
    - Numero di partecipanti con una o più reazioni avverse gravi (SAR) ai IV cristalloidi in ICU.
    - 90 giorni di sopravvivenza senza supporto vitale (vasopressore / supporto
    inotropico, ventilazione meccanica invasiva o terapia sostitutiva renale)
    - 90 giorni di sopravvivenza dopo la dimissione dall'ospedale
    - Mortalità per tutte le cause a 1 anno dopo la randomizzazione
    - HRQoL 1 anno dopo la randomizzazione misurata utilizzando i punteggi EuroQoL (EQ)-5D-5L e EQ-VAS. Ai partecipanti che sono morti verranno assegnati i punteggi più bassi possibili
    - Funzione cognitiva 1 anno dopo la randomizzazione come valutata dal punteggio di valutazione cognitiva di Montreal (MoCa)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Durante l'ammissione all'ICU, il giorno 90 dopo la randomizzazione o 1 anno dopo la randomizzazione
    Durante l'ammissione all'ICU, il giorno 90 dopo la randomizzazione o 1 anno dopo la randomizzazione
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Stesso farmaco ad altro dosaggio
    Same drug at another dosage
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    E.8.7Trial has a data monitoring committee No
    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 years2
    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 years2
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 754
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 800
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-05-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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
    La sperimentazione non può essere eseguita in persone coscienti, poiché non esiste alcun modello clinicamente rilevante di shock settico e nessun paziente cosciente ha la combinazione di infezione grave e shock come nei pazienti settici
    La sperimentazione non può essere eseguita in persone coscienti, poiché non esiste alcun modello clinicamente rilevante di shock settico e nessun paziente cosciente ha la combinazione di infezione grave e shock come nei pazienti settici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 1554
    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)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Centre of Research in Intensive Care - CRIC
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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