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    Summary
    EudraCT Number:2015-005112-15
    Sponsor's Protocol Code Number:TARTARE-2S-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-03
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-005112-15
    A.3Full title of the trial
    TARGETED TISSUE PERFUSION VERSUS MACROCIRCULATORY-GUIDED
    STANDARD CARE IN PATIENTS WITH SEPTIC SHOCK (TARTARE-2S)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TISSUE PERFUSION IN SEPTIC SHOCK
    A.3.2Name or abbreviated title of the trial where available
    TARTARE-2S
    A.4.1Sponsor's protocol code numberTARTARE-2S-01
    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 SponsorInselspital, Universitätspital Bern
    B.1.3.4CountrySwitzerland
    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 supportSigrid Juselius Foundation
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInselspital, Universitätspital Bern
    B.5.2Functional name of contact pointDepartment of Intensive Care
    B.5.3 Address:
    B.5.3.1Street AddressFreiburgstrasse
    B.5.3.2Town/ cityBern
    B.5.3.3Post codeCH-3010
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41031 632 53 00
    B.5.5Fax number+41031 632 17 71
    B.5.6E-mailStephan.Jakob@insel.ch
    D. IMP Identification
    D.IMP: 1
    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 Noradrenalin SAD
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNOREPINEPHRINE
    D.3.9.1CAS number 51-41-2
    D.3.9.4EV Substance CodeSUB09360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.01 per minute
    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
    Critically ill adult patients with septic shock
    E.1.1.1Medical condition in easily understood language
    Septic shock
    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 LLT
    E.1.2Classification code 10040050
    E.1.2Term Sepsis NOS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if tissue targeted monitoring/treatment compared to
    macrocircutory guided monitoring/treatment in septic shock patients
    increases days alive in 30 days without vasoactive drugs and without
    hyperlactatemia
    E.2.2Secondary objectives of the trial
    To compare the trial arms regarding organ dysfunction, supportive
    treatments, and mortality.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Several laboratory substudies prespecified in the study protocol
    E.3Principal inclusion criteria
    1. Infection (suspected or confirmed) AND
    2. systemic mean blood pressure > 65 mmHg requiring any dose of
    vasopressors (norepinephrine, vasopressin) despite adequate fluid
    resuscitation (minimum of 20 ml/kg crystalloids) AND
    3. Elevated lactate ≥ 3.0 mmol/L with suspected hypoperfusion
    E.4Principal exclusion criteria
    • aged less than 18 or over 80 years
    • any other probable condition than sepsis affecting or expected to
    affect the central nervous system including post cardiac arrest
    • myocardial ischemia
    • acute pulmonary embolism
    • terminal illness and not considered for full intensive care support
    • use of extra-corporeal membrane oxygenation (ECMO)
    • known liver disease - Child-Pugh –Class B or C
    • known chronic kidney disease
    • known to be pregnant or lactating
    E.5 End points
    E.5.1Primary end point(s)
    Days alive in 30 days - with normal arterial blood lactate ( first
    confirmed value of < 2 mmol/L AND without any inotropic or
    vasopressor agent
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    E.5.2Secondary end point(s)
    Secondary outcome measures
    a. Time to normalization of lactate
    b. Days alive with normal lactate in 30 days
    c. Days alive without any inotropic or vasopressor agent in 30 days
    d. Days alive without RRT in 30 days
    e. Days alive without mechanical ventilation in 30 days
    f. Days alive without any organ support (mechanical ventilation, renalreplacement
    therapy) in 30 days
    g. New AKI according to the KDIGO classification (Stages I-III)
    h. Days alive outside hospital in 90 days
    i. Total amount of norepinephrine given up to day 5
    j. Number/ total number of the following adverse reactions:
    ventricular tachycardia/ fibrillation
    atrial fibrillation
    myocardial infarction
    skin necrosis
    stroke
    secondary bowel ischemia
    limb ischemia
    numbers of serious adverse events
    Exploratory outcomes:
    k. All-cause mortality at day 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    0 to 90 days.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different monitoring strategy/ treatment goals
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 No
    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
    90 days
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 2016-06-03. 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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The trial cannont be performed in conscious persons, as no clinically relevant model of septic shock exists and no conscious persons have the combination of severe infection and shock as patients with septic shock have.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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
    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 Helsinki University Hospital
    G.4.3.4Network Country Finland
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Bern University Hospital
    G.4.3.4Network Country Switzerland
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Tampere University Hospital
    G.4.3.4Network Country Finland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-31
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