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    Summary
    EudraCT Number:2011-004232-66
    Sponsor's Protocol Code Number:AOIFUTIER2011
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-20
    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 number2011-004232-66
    A.3Full title of the trial
    Influence d’une stratégie de prévention des hypotensions artérielles peropératoires chez les patients à risques élevés de complications postopératoires :
    étude multicentique prospective randomisée contrôlée
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence d’une stratégie de prévention des hypotensions artérielles peropératoires chez les patients à risques élevés de complications postopératoires :
    étude multicentique prospective randomisée contrôlée
    A.3.2Name or abbreviated title of the trial where available
    InPRESS
    A.4.1Sponsor's protocol code numberAOIFUTIER2011
    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 SponsorCHU de Clermont-Ferrand
    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 supportCHU de Clermont-Ferrand
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointLacarin
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number003304 73 751 195
    B.5.5Fax number003304 73 754 730
    B.5.6E-mailplacarin@chu-clermontferrand.fr
    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 NORADRENALINE (TARTRATE) AGUETTANT 2 mg/ml (SANS SULFITES) sol diluer p perf
    D.2.1.1.2Name of the Marketing Authorisation holderAguettant
    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.3.1Product namenorépinéphrine tartrate
    D.3.4Pharmaceutical form Injection
    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.3.9.3Other descriptive nameNORADRENALINE TARTRATE
    D.3.9.4EV Substance CodeSUB12179MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 EPHEDRINE AGUETTANT 3 mg/ml sol inj en seringue préremplie
    D.2.1.1.2Name of the Marketing Authorisation holderAguettant
    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.3.1Product nameéphédrine chlorhydrate
    D.3.4Pharmaceutical form Injection
    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.3.9.3Other descriptive nameEPHEDRINE HYDROCHLORIDE, RACEMIC
    D.3.9.4EV Substance CodeSUB11935MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    L'étude a pour objectif de comparer un traitement prévemptif de l’hypotension artérielle peropératoire par perfusion continue de noradrénaline par rapport et traitement curatif de l’hypotension artérielle lors de l’anesthésie générale sur le risque de dysfonction d’organes en postopéraoire.
    E.1.1.1Medical condition in easily understood language
    L'étude a pour objectif de comparer un traitement préventif de l’hypotension artérielle peropératoire lors de l’anesthésie générale sur le risque de dysfonction d’organes en postopéraoire.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Déterminer si une stratégie préventive de prise en charge des hypotensions artérielles en utilisant une perfusion continue de noradrénaline et visant à maintenir une PAS à ± 10% de sa valeur de référence, permet une réduction du risque de dysfonctions d’organes en postopératoire par rapport au standard de soins habituel (traitement curatif de l’hypotension artérielle) consistant en une administration itérative de boli de chlorhydrate d’éphédrine
    E.2.2Secondary objectives of the trial
    - Déterminer si l’administration continue de noradrénaline permet de diminuer les nombres d’hypotension artérielle, d’hypertension artérielle et de bradycardie en peropératoire
    - Déterminer si si l’administration continue de noradrénaline permet une amélioration de la stabilité hémodynamique peropératoire.
    - Déterminer si l’administration continue de noradrénaline permet une réduction de l’incidence des dysfonctions cognitives postopératoires
    - Déterminer si l’administration continue de noradrénaline permet une accélération de la réhabilitation postopératoire, jugée sur :
    - Déterminer si l’administration continue de noradrénaline permet une épargne transfusionnelle periopératoire
    - Déterminer si l’administration continue de noradrénaline permet une réduction les volumes de fluides (cristalloïde et colloïde) administrés en peropératoire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 50 ans
    - Score ASA ≥ II
    - Chirurgie réglée ou en urgence
    - Chirurgie abdominale, orthopédique et vasculaire sous anesthésie générale
    - Durée estimée de chirurgie > 2 heure
    - AKI risk index ≥ classe 3. Cet index est associé à un risque élevé de dysfonction rénale postopératoire. (10) (cf Annexe 2)
    E.4Principal exclusion criteria
    - Hypertension artérielle sévère non traitée ou non équilibrée sous traitement
    - Insuffisance rénale préopératoire avec clairance de la créatinine plasmatique < 30 ml/min ou dialysée
    - Insuffisance cardiaque aigue
    - Insuffisance coronarienne aigue
    - Chirurgie vasculaire avec plastie rénale
    - Sepsis préopératoire
    - Etat de choc préopératoire
    - Perfusion continue de noradrénaline préopératoire
    - Anesthésie sous anesthésie loco-régionale (rachianesthésie et péridurale)
    - Refus de participation du patient
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal est un critère composite associant l’existence d’un syndrome inflammatoire réponse systémique (SIRS) et au moins une défaillance d’organe en postopératoire survenant dans les 7 jours:
    - Défaillance rénale
    - Défaillance cardiovasculaire
    - Défaillance respiratoire
    - Défaillance neurologique
    - Défaillance hématologique
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 jours post-opératoire
    E.5.2Secondary end point(s)
    - Incidence des hypotensions artérielles peropératoires (PAS < 80 mmHg ou PAS < 40% de la valeur de base)
    - Incidence des hypertensions artérielles peropératoires (PAS > 160 mmHg et/ou PAD > 90 mmHg)
    - Incidence de bradycardie sévère (définie par une fréquence cardiaque < 40 c/min)
    - Stabilité hémodynamique peropératoire évaluée sur la différence des aires sous la courbe de pression artérielle systolique
    - Dysfonction cognitive postopératoire jugée sur le test DSST à J1, J2 et J7 postopératoires
    - Pertes sanguines et incidence d’épisodes hémorragiques sévères en peropératoire. Un épisode hémorragique sévère est défini par des pertes sanguines > 500 ml.
    - Nombre de concentrés globulaires en peropératoire
    - Diurèse peropératoire et à J1 et J2 postopératoires
    - Scores de RIFLE et AKIN à J1, J2 et J7 postopératoires (Annexe 3)
    - Incidence d’épuration rénale (EER) postopératoire
    - Volume de fluides (cristalloïde et colloïde) administrés en peropératoire
    - Nombre de « Rescue Therapy » dans les 2 groupes (cf page 17 du document)
    - Incidence de complications postopératoires : cardiovasculaires (troubles du rythme cardiaque (tachycardie), œdème aigu du poumon, infarctus du myocarde, insuffisance cardiaque aigue, accident vasculaire cérébral), inflammatoires (syndrome inflammatoire de réponse systémique ou SIRS), infectieuses (fistule anastomotique, infection du site opératoire, pneumopathie, infection urinaire, sepsis, sepsis sévère et choc septique), respiratoires (hypoxémie, hypercapnie, nécessité de recours à une assistance ventilatoire invasive ou non-invasive), thromboemboliques (thrombose veineuse profonde, embolie pulmonaire), hématologiques (thrombopénie, leucopénie). Les définitions des complications sont fournies en annexe (annexe 6) du protocole.
    - Durée de séjour hospitalier
    - Mortalité postopératoire à J30 et 1 an
    - Critères biologiques :
    • Concentration de NGAL à J1, J2 et J7 postopératoire
    • Créatininémie plasmatique mesurée à J0, J1, J2 et J7 postopératoire
    • Lactatémie plasmatique mesurée à J1, J2 et J7 postopératoire
    • C Réactive protéine mesurée à J1, J2 et J7 postopératoire
    • Troponine Tc mesurée à J1, J2 et J7 postopératoire
    • NT pro Brain Natriuretic Peptide (NT proBNP) mesurée à J1, J2 et J7 postopératoire
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 jours post-opératoire
    30 jours post-opératoire
    1 an post-opératoire
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 concerned7
    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 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
    La fin de l'étude correspond à la l'évaluation de l'état de santé 1 an post-opératoire (Mortalité oui ou non).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 300
    F.1.3Elderly (>=65 years) No
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    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)
    Not different from the expected normal treatment
    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 Decision2011-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-28
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