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    Summary
    EudraCT Number:2018-002525-35
    Sponsor's Protocol Code Number:ICUConservativeO2
    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:2021-02-09
    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 number2018-002525-35
    A.3Full title of the trial
    Conservative vs conventional oxygen administration in critically ill patients: effects on ICU mortality. A multicentre randomized open label clinical trial.
    Somministrazione di ossigeno conservativa vs convenzionale nel paziente critico: effetti sulla mortalità in terapia intensiva. Uno studio clinico multicentrico randomizzato controllato in aperto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Conservative vs conventional oxygen administration in critically ill patients: effects on ICU mortality. A multicentre randomized open label clinical trial.
    Somministrazione di ossigeno conservativa vs convenzionale nel paziente critico: effetti sulla mortalità in terapia intensiva. Uno studio clinico multicentrico randomizzato controllato in aperto.
    A.3.2Name or abbreviated title of the trial where available
    Conservative vs conventional oxygen administration in critically ill patients
    Somministrazione di ossigeno conservativa vs convenzionale nel paziente critico
    A.4.1Sponsor's protocol code numberICUConservativeO2
    A.5.4Other Identifiers
    Name:ICUConservativeO2Number:ICUConservativeO2
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    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 supportESICM
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria di Modena
    B.5.2Functional name of contact pointClinical Trial Quality Team
    B.5.3 Address:
    B.5.3.1Street Addressvia del Pozzo 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594225868
    B.5.5Fax number0594224369
    B.5.6E-mailricercainnovazione@policlinico.mo.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 OSSIGENO CER MEDICAL - GAS MEDICINALE CRIOGENICO CONTENITORE CRIOGENICO FISSO DA 5.000 LITRI
    D.2.1.1.2Name of the Marketing Authorisation holderCER MEDICAL SRL
    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 nameossigeno 100%
    D.3.2Product code [V03AN01]
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeossigeno
    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
    adult critically ill patients requiring non-invasive (NIMV) or invasive mechanical ventilation (IMV)
    Pazienti critici adulti che necessitano di ventilazione meccanica non invasiva (NIMV) o invasiva (IMV)
    E.1.1.1Medical condition in easily understood language
    adult critically ill patients requiring non-invasive (NIMV) or invasive mechanical ventilation (IMV)
    Pazienti critici adulti che necessitano di ventilazione meccanica non invasiva (NIMV) o invasiva (IMV)
    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 10040047
    E.1.2Term Sepsis
    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
    To verify the hypothesis that strict maintenance of normoxia improves survival in a wide population of mechanically ventilated critically ill patients compared to the application of conventional more liberal strategies of oxygen administration. Survival will be measured at ICU discharge.
    L’obiettivo primario di questo studio è verificare l’ipotesi secondo la quale un rigoroso mantenimento di uno stato di normossia migliora la sopravvivenza in un’ampia popolazione di pazienti critici meccanicamente ventilati, se confrontata all’applicazione di strategie più liberali di somministrazione di ossigeno. La sopravvivenza sarà valutata alla dimissione dalla Terapia Intensiva.
    E.2.2Secondary objectives of the trial
    To verify the hypothesis that, in a wide population of mechanically ventilated critically ill patients, the strict maintenance of normoxia compared to the application of conventional more liberal strategies of oxygen administration reduces the 90-day mortality, onset of new organ failures during ICU stay, occurrence of nosocomial infections during ICU stay (only microbiologically documented bloodstream, respiratory and surgical site infections will be considered), the length of mechanical ventilation, vasopressor use and ICU stay, the occurrence of ICU acquired weakness and cognitive dysfunction
    The confirmation of the efficacy of a conservative strategy for oxygen administration in reduce the mortality rate among critically ill patients will lead to a profound revision of the current clinical practice and a rationale revision of the current recommendations would be mandatory, maybe also in other clinic
    Gli obiettivi secondari si occupano di verificare l’ipotesi secondo cui il rigoroso mantenimento di uno stato di normossia, confrontato con l’applicazione di strategie convenzionali più liberali nella somministrazione di ossigeno, riduce la mortalità a 90 giorni, l’insorgenza di nuove insufficienze d’organo durante il ricovero in Terapia Intensiva, la durata della ventilazione meccanica, l’uso di farmaci vasoattivi, la permanenza in Terapia Intensiva e riduce anche l’insorgenza di debolezza Terapia Intensiva-realata e di disfunzione cognitiva.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: IMMUNE-O2 Sub-study vs 1 del 12-03-2018.
    The objectives of the IMMUNE-O2 sub-study are to evaluate the relationship between different levels of arterial PO2 and the immune immune-system in critically ill patients and to verify the hypothesis that strict maintenance of normoxia compared to the application of conventional more liberal strategies of oxygen administration reduces the impairment of immune-system in critically ill patients.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: IMMUNE-O2 Sub-study vs 1 del 12-03-2018.
    Gli obiettivi del sottostudio IMMUNE-O2 sono di valutare la relazione tra i diversi livelli di PO2 arteriosa e il sistema immunitario immune nei pazienti critici e di verificare l'ipotesi che il mantenimento rigoroso della normossia rispetto all'applicazione di strategie convenzionali più liberali per somministrazione di ossigeno riduce la compromissione del sistema immunitario nei pazienti critici.
    E.3Principal inclusion criteria
    - Critically ill patients admitted to participant ICUs,
    - Age = 18 years without regards about sex and ethnicity;
    - Expected length of ICU stay of more than 72 hours.
    - Need of any respiratory support (IMV or NIMV) at admission and with an expected length of respiratory support = 6 hours
    - Acquisition of informed consent.
    - Pazienti in condizioni critiche ammesse alle ICU partecipanti,
    - Età = 18 anni senza distinzione di sesso ed etnia;
    - Durata prevista della permanenza in ICU di oltre 72 ore.
    - Necessità di qualsiasi supporto respiratorio (IMV o NIMV) al momento del ricovero e con una durata prevista del supporto respiratorio = 6 ore
    - Acquisizione del consenso informato
    E.4Principal exclusion criteria
    - Pregnancy: Patients who are known to be pregnant or with a positive serum pregnancy test will be excluded. All potentially fertile females will be tested for pregnancy before enrolment in the study. We will consider as potentially fertile all female patients between 18 and 55 with no documented evidence of menopause, hysterectomy, surgical sterilization
    - Admission to ICU after elective surgery
    - ICU readmission (after a first discharge) in the study period;
    - IMV or NIMV greater than 12 hours in the 28 days before study inclusion;
    - Clinical decision to withhold life-sustaining treatment or “too sick to benefit” or patients with a life expectancy of less than 28 days due to a chronic or underlying medical condition.
    - Previous enrolment in other interventional studies of targeted oxygen therapy;
    - Acute respiratory failure on chronic obstructive pulmonary disease
    - Acute respiratory distress syndrome (ARDS) with a PaO2/FiO2 ratio < 150.
    - Long-term supplemental oxygen therapy.
    - Patients candidate to hyperoxia treatment for reasons including (but not limited to) carbon monoxide poisoning or to hyperbaric oxygen therapy;
    - Gravidanza:Saranno escluse le pazienti in gravidanza o con un test di gravidanza positivo. Tutte le donne potenzialmente fertili effettueranno un test di gravidanza prima dell'arruolamento nello studio. Considereremo fertili tutte le pazienti di sesso femminile tra i 18 ei 55 anni senza evidenza documentata di menopausa, isterectomia, sterilizzazione chirurgica;
    - Ammissione alla terapia intensiva dopo chirurgia elettiva
    - riammissione ICU (dopo una prima dimissione) nel periodo di studio;
    - IMV o NIMV superiori a 12 ore nei 28 giorni precedenti l'inclusione nello studio;
    - Decisione clinica di sospendere il trattamento di mantenimento della vita o "troppo malato per beneficiare" o di pazienti con un'aspettativa di vita inferiore a 28 giorni a causa di una condizione medica cronica o di base.
    - Iscrizione precedente ad altri studi interventistici di ossigenoterapia mirata;
    - Insufficienza respiratoria acuta nella broncopneumopatia cronica ostruttiva
    - Sindrome da distress respiratorio acuto (ARDS) con un rapporto PaO2 / FiO2 <150.
    - Ossigenoterapia supplementare a lungo termine.
    - I pazienti candidati al trattamento con iperossia per ragioni che includono (ma non limitato a) avvelenamento da monossido di carbonio o ossigenoterapia iperbarica;
    E.5 End points
    E.5.1Primary end point(s)
    ICU mortality rate, defined as the number of deaths for any cause occurred during the ICU stay (censored at 90 days)
    Tasso di mortalità in ICU, definito come il numero di decessi per qualsiasi causa verificatosi durante la permanenza in terapia intensiva (censurato a 90 giorni)
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days
    90 giorni
    E.5.2Secondary end point(s)
    The occurrence of new organ dysfunction defined as a Sequential Organ Failure Assessment (SOFA) score =3 for the corresponding organ), occurring =48 hours after ICU admission; bloodstream, respiratory and surgical site infections (defined according to CDC definitions20). Only microbiologically documented bloodstream and respiratory tract infections were considered.; Ventilation-free hours (VFHs) during the ICU stay. VFHs is defined as the total number of hours of unassisted breathing between randomisation and ICU discharge. Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the VFH calculation. Patients who are receiving extracorporeal membrane oxygenation (ECMO) will be defined as receiving assisted breathing irrespective of whether they are ventilated or not; Vasopressor free-hours (VasoFHs) during the ICU stay. VasoFHs is defined as the total number of hours without vasoactive drugs infusion used for hypotension between randomisation and ICU discharge.; Time to hospital discharge (censored at 90 days)
    L'insorgenza di una nuova disfunzione d'organo definita come un punteggio di insufficienza d'organo sequenziale (SOFA) =3 per l'organo corrispondente), che si verifica =48 ore dopo l'ammissione all'ICU; infezioni del flusso sanguigno, respiratorie e del sito chirurgico (definite secondo le definizioni CDC20). Sono state prese in considerazione solo le infezioni del flusso sanguigno e delle vie respiratorie microbiologicamente documentate.; Le ore senza ventilazione (VFH) durante la permanenza in ICU . VFHs è definito come il numero totale di ore di respiro non assistito tra randomizzazione e dimissione in ICU. I periodi di respirazione assistita della durata inferiore a 24 ore per le procedure chirurgiche non verranno conteggiati rispetto al calcolo del VFH. I pazienti che ricevono ossigenazione della membrana extracorporea (ECMO) saranno definiti come soggetti a respirazione assistita indipendentemente dal fatto che siano ventilati o meno; Le ore libere di Vasopressore (VasoFH) durante la permanenza in terapia intensiva. VasoFHs è definito come il numero totale di ore senza infusione di farmaci vasoattivi utilizzati per ipotensione tra randomizzazione e dimissione dall'ICU.; Tempo di dimissione dall'ospedale (censurato a 90 giorni)
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours ; 90 days; during the ICU stay; during the ICU stay; 90 days
    48 ore; 90 giorni; durante la permanenza in ICU; durante la permanenza in terapia intensiva; 90 giorni
    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 No
    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 No
    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 EEA5
    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 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 years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 2021-02-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    Subjects incapable of giving consent personally, please specify: the subjects enrolled in the study may be patients who are temporarily unconscious or for reasons related to their pathology or by pharmacological sedation. In this case, the local coor
    potranno essere pazienti incoscienti temporaneamente o per ragioni legate alla loro patologia o per sedazione farmacologica. In questo caso, il coordinatore locale (sperimentatore) potrà decidere di arruolare comunque il paziente per il suo interesse
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state550
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 1000
    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)
    best supportive care
    miglior terapia di supporto
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-31
    P. End of Trial
    P.End of Trial StatusOngoing
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