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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-003012-31
    Sponsor's Protocol Code Number:2011RC23r
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2012-003012-31
    A.3Full title of the trial
    Cardiovascular effects of esmolol alone and in combination with levosimendan during septic shock
    Effets cardiovasculaires associés à l'administration d'esmolol seul et en association au lévosimendan chez le patient en choc septique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cardiovascular effects of esmolol alone and in combination with levosimendan during septic shock
    Effets cardiovasculaires associés à l'administration d'esmolol seul et en association au lévosimendan chez le patient en choc septique
    A.4.1Sponsor's protocol code number2011RC23r
    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 SponsorDIRECTION CENTRALE DU SERVICE DE SANTE DES ARMEES
    B.1.3.4CountryFrance
    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 supportDirection Centrale Du Service de Sante des Armées
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de recherche biomedicale des armées
    B.5.2Functional name of contact pointChef du BuCHU
    B.5.3 Address:
    B.5.3.1Street AddressBP 73
    B.5.3.2Town/ cityBRETIGNY SUR ORGE
    B.5.3.3Post code91223
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)169238101
    B.5.5Fax number33(0)169237002
    B.5.6E-mailcelluleprojets@gmail.com
    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 BREVIBLOC
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMPIntravenous use
    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.2.1.1.1Trade name SIMDAX
    D.2.1.1.2Name of the Marketing Authorisation holderORION PHARMA
    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 IMPIntravenous use
    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
    Évaluation de la tolérance hemodynamique
    E.1.1.1Medical condition in easily understood language
    Patients avec un choc septique récent
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    NO
    Notre hypothèse principale est que l’administration de béta-1 bloquant dans un contexte de choc septique améliore les dysfonctions d’organe via une modification de la balance sympatho-vagale au profit du contrôle parasympathique cardiaque, altéré dans le contexte du choc septique
    E.2.2Secondary objectives of the trial
    No
    - que l’administration de béta-1 bloquant améliore la performance du myocarde septique
    - que l’administration de béta-1 bloquant améliore la réponse immune et diminue l’inflammation
    - que l’ensemble de ces propriétés améliore la morbidité (durée de séjour en réanimation, durée de ventilation mécanique) des patients en état de choc septique
    - que le lévosimendan conserve ses propriétés inotropes chez les patients béta-bloqués en choc septique
    Néanmoins, vu que les effets des béta bloquants n’ont pas été évalués d’une manière très rigoureuse chez l’homme, avant de démarrer une étude randomisée versus placebo il nous semble important de confirmer la bonne tolérance sur une étude pilote bien encadrée.
    De plus, nous souhaitons également confirmer sur une étude pilote, les capacités inotropes du lévosimendan dans le choc septique sous béta bloquant de manière à l’inclure comme thérapeutique de la défaillance myocardique septique chez le patient béta bloqué.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    NO
    Choc septique, à savoir : SIRS d’origine septique (au moins deux critères) et PAS restant inférieure ou égale à 90mmHg après remplissage vasculaire de 40ml/kg ou lactates ≥ 4mmol/l (nécessité de vasopresseurs)
    • Moins de 24 heures de début du choc septique
    • Après une heure de stabilité hémodynamique définie par une atteinte des objectifs sans modification des thérapeutiques
    E.4Principal exclusion criteria
    NO
    • refus du patient ou de la personne de confiance
    • posologie de noradrénaline supérieure à 4mg/h
    • administration de dobutamine ou d’adrénaline
    • insuffisance cardiaque congestive décompensée
    • ITV sous aortique inférieure à 14cm
    • bloc auriculo-ventriculaire de haut degré
    • arythmie complète par fibrillation auriculaire
    • patient mineur ou femme enceinte, ou allaitant
    • participation à un autre essai clinique
    • arrêt cardiaque
    • bradycardie (en pratique pour respecter le protocole FC <60bpm)
    • asthme sévère ou non équilibré
    • BPCO sévère ou non équilibrée
    E.5 End points
    E.5.1Primary end point(s)
    NO
    Le critère d’évaluation principal choisi pour l’étude est l’évolution du débit cardiaque durant la période d’observation, mesuré par thermodilution transpulmonaire et par l’analyse du contour de l’onde de pouls avec le moniteur Picco plus ®. Une baisse initiale du débit cardiaque est attendue durant la première heure d’administration avant un retour aux valeurs initiales
    E.5.1.1Timepoint(s) of evaluation of this end point
    NO
    Evaluation continue durant l'étude
    E.5.2Secondary end point(s)
    Les critères d’évaluation secondaires visent à préciser les effets du bétabloquant sur :
    - l’inotropisme, par évaluation échographique : FEVG, FEVD, fonction systolique doppler tissulaire, indice de Tei, pressions de remplissage VG et VD.
    - la fréquence cardiaque, la pression artérielle,
    - le lactate sérique,
    - les composantes du système nerveux autonome cardiaque basé sur l’analyse spectrale de l’intervalle RR extrait du tracé electrocardiographique* :
    o Puissance spectrale totale
    o Puissances spectrales de basses et hautes fréquences ainsi que leur ratio (balance sympatho-vagale cardiaque)
    - Paramètres issus de l’analyse spectrale de la variabilité de la pression artérielle systolique, permettant d’évaluer le contrôle sympathique vasculaire* :
    o Puissance spectrale de basses fréquences
    o Paramètres permettant une estimation de l’efficacité du baroreflexe spontané, calculés d’une part par la méthode des séquences (1), et d’autre part par l’analyse cross-spectrale de la variabilité de l’intervalle RR et de la variabilité de pression artérielle systolique (2), permettant d’évaluer le contrôle baroréflexe cardiaque
    o Gain du baroréflexe calculé sur des séquences de 3 battements (1), et dans la bande de basses fréquences (2).
    * Il s’agit de la mesure de la puissance spectrale totale indice de variabilité globale du signal (aire sous la courbe, basses fréquences (0,04 à 0,15 Hz) reflet du contrôle sympathique et parasympathique cardiaque et hautes fréquences (0,15 à 0,4 Hz) reflet de l’activité du parasympathique à destinée sinusale. La même méthodologie sera appliquée sur le signal direct de la pression artérielle recueilli de façon invasive classique (cathéter intra-arteriel) ; cette investigation de la variabilité de pression artérielle couplée à celle de l’intervalle RR, permettra une évaluation de l’activité sympathique à destinée vasculaire ainsi qu’une évaluation de l’efficacité du baroréflexe cardiaque.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NO
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    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 No
    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 No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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 Decision2013-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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