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    Summary
    EudraCT Number:2020-004881-20
    Sponsor's Protocol Code Number:NORDIST
    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:2021-06-01
    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 number2020-004881-20
    A.3Full title of the trial
    Comparison of norepinephrine and dobutamine in patients in cardiogenic shock
    Confronto fra Noradrenalina e Dobutamina nei pazienti in shock cardiogeno
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of norepinephrine and dobutamine in patients in cardiogenic shock
    Confronto fra Noradrenalina e Dobutamina nei pazienti in shock cardiogeno
    A.3.2Name or abbreviated title of the trial where available
    NORDIST
    NORDIST
    A.4.1Sponsor's protocol code numberNORDIST
    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 USL TOSCANA SUD EST Sezione di Arezzo
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale della Misericordia, Grosseto
    B.5.2Functional name of contact pointU.O.C. Cardiologia
    B.5.3 Address:
    B.5.3.1Street AddressVia Senese 161
    B.5.3.2Town/ cityGrosseto
    B.5.3.3Post code58100
    B.5.3.4CountryItaly
    B.5.4Telephone number0564483276
    B.5.6E-mailugo.limbruno@uslsudest.toscana.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 DOBUTAMINA (BIOINDUSTRIA LI.M.)
    D.2.1.1.2Name of the Marketing Authorisation holderBIOINDUSTRIA LIM Laboratorio Italiano Medicinali S.p.A. Via De Ambrosiis, 2 - 15067 Novi Ligure (AL)
    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 nameDOBUTAMINA (BIOINDUSTRIA LI.M.)
    D.3.2Product code [034449013]
    D.3.4Pharmaceutical form Concentrate for 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 INNDOBUTAMINA CLORIDRATO
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3000
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 NORADRENALINA TARTRATO (GALENICA SENESE)
    D.2.1.1.2Name of the Marketing Authorisation holderINDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.
    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 nameNORADRENALINA TARTRATO (GALENICA SENESE)
    D.3.2Product code [034808028]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNNORADRENALINA TARTRATO
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number144
    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
    Patients over 18 years of age with cardiogenic shock
    Tutti i pazienti di età superiore a 18 anni che si trovano in stato di shock cardiogeno.
    E.1.1.1Medical condition in easily understood language
    Patients over 18 years of age with cardiogenic shock
    Tutti i pazienti di età superiore a 18 anni che si trovano in stato di shock cardiogeno.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040563
    E.1.2Term Shock cardiogenic
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040563
    E.1.2Term Shock cardiogenic
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007625
    E.1.2Term Cardiogenic shock
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007625
    E.1.2Term Cardiogenic shock
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007625
    E.1.2Term Cardiogenic shock
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007625
    E.1.2Term Cardiogenic shock
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of blood lactate concentration variation between the baseline and 72 hours after randomization, in the two treatment arms.
    Valutare la differenza nella variazione della concentrazione ematica dei lattati al basale e dopo 72 ore dalla randomizzazione, nei due bracci di trattamento.
    E.2.2Secondary objectives of the trial
    Evaluation of the incidence of death or the need to receive ECMO (Extracorporeal membrane oxygentaion) / LVAD (Left ventricular Assist Device) implantation at 72 hours after randomization and at discharge.
    Valutare l’incidenza di decesso o necessità di ricevere impianto di ECMO (Extracorporeal membrane oxygentaion)/LVAD (Left ventricular Assiste Device) a 72 ore dalla randomizzazione e alla dimissione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cardiogenic shock with: systolic systemic blood pressure (PAS) <90 mmHg or mean arterial pressure (MAP) <60 mmHg for at least 30 consecutive minutes and the need for pharmacological support (inotropic and / or vasopressors) to maintain a PAS> 90 mmHg or MAP > 60 mmHg;
    Over the age of 18;
    Enrollment within 3 hours of the acute event,
    Shock cardiogeno con: pressione arteriosa sistemica sistolica (PAS) < 90 mmHg o pressione arteriosa media (MAP) < 60 mmHg per almeno 30 minuti consecutivi e necessità di supporto farmacologico (inotropi e/o vasopressori) per mantenere una PAS > 90 mmHg o MAP > 60 mmHg;
    Età superiore ai 18 anni;
    Arruolamento entro 3 ore dall’evento acuto,
    E.4Principal exclusion criteria
    Pregnancy in progress;
    Presence of at least moderate aortic and / or mitral valve disease;
    Septic or hypovolemic shock
    Mechanical complications of acute myocardial infarction (rupture of the free wall of the heart, interventricular defect, papillary rupture.
    Arrhythmic storm, persistent or chronic tachycardic atrial fibrillation.
    Patient enrolled in another study
    Infusion of inotropes / vasoconstrictors already in place at the time of randomization
    Gravidanza in atto;
    Presenza di valvulopatia valvolare aortica e/o mitralica almeno moderata;
    Shock settico o ipovolemico;
    Complicanze meccaniche dell’infarto acuto del miocardio (rottura di parete libera del cuore, difetto interventricolare, rottura di papillare.
    Storm aritmico, fibrillazione atriale tachicardica persistente o cronica.
    Paziente arruolato in altro studio
    Infusione di inotropi/vasocostrittori già in atto al momento della randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    Variation of blood lactate concentration measured as the difference between maximum value at baseline: 0-1 hours after randomization and 72 hours after randomization, in the two treatment arms.
    In case of death: Variation of blood lactate concentration measured as the difference between maximum value at baseline: 0-1h from randomization and last available lactate value from randomization, in both of arms of treatment.
    Variazione della concentrazione ematica di lattato misurata come la differenza tra valore massimo al basale: 0-1 ore dalla randomizzazione e a 72 ore dalla randomizzazione, nei due bracci di trattamento.
    In caso di decesso: variazione della concentrazione ematica di lattato misurata come la differenza tra valore massimo al basale: 0-1h dalla randomizzazione e ultimo valore di lattato disponibile dalla randomizzazione, nei due bracci di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - at basal time: 0-1 hours after randomization
    - at 72 hours after randomization
    - In case of death: at basal time 0-1 hours after randomization and the last available blood lactate value
    - al tempo basale: 0-1 ore dopo la randomizzazione
    - a 72 ore dopo la randomizzazione
    - In caso di decesso: al tempo basale: 0-1 ore dopo la randomizzazione e l'ultimo valore di lattato disponibile
    E.5.2Secondary end point(s)
    1-death or need for ECMO / LVAD at 72 h from randomization
    2-death or need to resort to ECMO / LVAD upon discharge
    3- Variation of SOFA (Sequential Organ Failure Assessment) score measured as the difference between maximum value at baseline: 0-1 hours after randomization and 72 hours after randomization; and between maximum value at baseline: 0-1 hours after randomization and 7 days after randomization, in both of arms of treatment.
    4-AUC of lactates (0-72 h)
    5-need for further inotropic extra trial at 72h
    1-decesso o necessità di ricorrere ad ECMO/LVAD a 72 h dalla randomizzazione
    2-decesso o necessità di ricorrere ad ECMO/LVAD alla dimissione
    3-variazione SOFA score tra basale (0-1 ora dalla randomizzazione) e 72 ore dalla randomizzazione e tra basale (0-1 ora dalla randomizzazione) e a 7 giorni dalla 4-randomizzazione
    4-AUC dei lattati (0-72 h)
    5-necessità di ulteriore inotropo extra trial a 72h
    E.5.2.1Timepoint(s) of evaluation of this end point
    - at basal time: 0-1 hours after randomization
    - at 72 hours after randomization
    - at 7 days after randomization
    - al tempo basale: 0-1 ore dopo la randomizzazione
    - a 72 ore dopo la randomizzazione
    - a 7 giorni 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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    EFFECTIVENESS
    EFFICACIA SUL CAMPO
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    1-consent withdrawal
    2-conclusion of treatment and / or follow-up (acquisition of anamnestic, clinical, laboratory, radiological data of individual study patients including follow up)
    3-interruption due to therapy failure or complications which in clinical judgment do not translate the continuation
    4-end of the analysis of the data of all eligible patients as well as of the final evaluation of the results with publication of specific documents
    1-per ritiro del consenso
    2-per conclusione del trattamento e/o del follow-up (acquisizione dei dati anamnestici, clinici, laboratoristici, radiologici dei singoli pazienti in studio compreso il follow up)
    3-per interruzione dovuta a fallimento della terapia o a complicanze che a giudizio clinico non ne consentono la prosecuzione
    4-termine dell’analisi dei dati di tutti i pazienti arruolabili nonché alla valutazione conclusiva dei risultati con pubblicazione dei documenti specifici.
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 No
    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
    Subjects in cardiogenic shock
    Soggetti in stato di shock cardiogeno
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 46
    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)
    At the end of the study, patients will be followed as per ministerial indications. A 30-day follow-up to verify the patient's state of health: carring out ECG, echocardiogram, blood tests, anamnesis and physical examination.
    Al termine dello studio, i pazienti saranno seguiti come da indicazioni ministeriali. E' previsto un follow up a 30 giorni per verificare lo stato di salute del paziente in quale verrà sottoposto ad ECG, ecocardiogramma, esami ematici, anamnesi ed esame obiettivo.
    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 Decision2021-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-18
    P. End of Trial
    P.End of Trial StatusOngoing
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