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    Summary
    EudraCT Number:2021-001827-41
    Sponsor's Protocol Code Number:PI2020_843_0094
    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:2021-04-08
    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 number2021-001827-41
    A.3Full title of the trial
    Evaluation of the early use of norepinephrine in major abdominal surgery on postoperative organ dysfunction
    Évaluation de l’utilisation préventive de la noradrénaline en chirurgie abdominale majeure sur la dysfonction d’organe post opératoire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the early use of norepinephrine in major abdominal surgery on postoperative organ dysfunction
    Évaluation de l’utilisation préventive de la noradrénaline en chirurgie abdominale majeure sur la dysfonction d’organe post opératoire
    A.3.2Name or abbreviated title of the trial where available
    EPON
    EPON
    A.4.1Sponsor's protocol code numberPI2020_843_0094
    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 Amiens-Picardie
    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 Amiens-Picardie
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Amiens-Picardie
    B.5.2Functional name of contact pointClinical project manager
    B.5.3 Address:
    B.5.3.1Street AddressDRCI, CHU Amiens-Picardie
    B.5.3.2Town/ cityAmiens
    B.5.3.3Post code80054
    B.5.3.4CountryFrance
    B.5.6E-mailmattoug.salah@chu-amiens.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 NORADRÉNALINE (TARTRATE) AGUETTANT 0,5 mg/mL
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE AGUETTANT
    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 nameNORADRÉNALINE
    D.3.4Pharmaceutical form Infusion
    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
    major abdominal surgery
    chirurgie abdominale majeure
    E.1.1.1Medical condition in easily understood language
    major abdominal surgery
    chirurgie abdominale majeure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    is to show the effectiveness of the preventive use of noradrenaline in major abdominal surgery on the occurrence of postoperative medical-surgical complication
    est de montrer l’efficacité de l’utilisation préventive de la noradrénaline en chirurgie abdominale majeure sur la survenue de complications médico-chirurgicales postopératoires.
    E.2.2Secondary objectives of the trial
    - Length of hospital stay and length of stay in the ICU
    - Post-operative renal function at 48 hours, 7 days and 1 month post-operatively.
    - Post-operative cardiovascular complications occurring during the stay
    - Post-operative respiratory complications occurring during the stay
    - Infectious complications
    - Neurological complications
    - Haematological complications
    - Volume of intraoperative vascular filling with crystalloids recorded at the end of the operation
    - Mortality at 1 month
    - Evaluation of the level of dependence in activities of daily living
    • Durée de séjour hospitalier et durée de séjour en réanimation/unité de soins continus
    • Fonction rénale postopératoire à quarante-huit heures, à sept jours et à un mois post opératoire.
    • Complications cardiovasculaires post opératoires survenant au cours du séjour
    • Complications respiratoires post opératoires survenant au cours du séjour
    • Complications infectieuses
    • Complications neurologiques
    • Complications hématologiques
    • Volume de remplissage vasculaire per opératoire par cristalloïdes relevé en fin d’intervention
    • Mortalité à 1 mois
    • Evaluation du niveau de dépendance dans les activités de la vie quotidienne
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult > 50 years
    • Major abdominal surgery
    • Weighing more than 50 kg
    • ASA 2 or more
    • General anaesthesia
    - Adulte > 50 ans
    - Chirurgie abdominale majeure
    - Pesant plus de 50 kg
    - ASA 2 ou plus
    - Anesthésie générale
    E.4Principal exclusion criteria
    o patient allergic to local anesthetics,
    o infection at the puncture sites,
    o patient on morphine analgesic over the long term,
    o patient on antidepressants for neuropathic pain.
    o Patient allergique aux anesthésiques locaux.
    o Infection aux points de ponction.
    o Patient sous antalgique morphinique au long cours.
    o Patient sous antidépresseurs pour douleurs neuropathiques.
    E.5 End points
    E.5.1Primary end point(s)
    is the occurrence of postoperative medical-surgical complications assessed by the Clavien Dindo surgical score.
    est la survenue de complications médico-chirurgicales postopératoires évaluées par le score chirurgical Clavien Dindo
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 30
    30 jours
    E.5.2Secondary end point(s)
    - Length of hospital stay and length of stay in the ICU at one month
    - Post-operative renal function assessed by KDIGO score at 48 hours, 7 days and 1 month post-operatively.
    - Post-operative cardiovascular complications occurring during the stay: circulatory shock defined by the use of catecholamines beyond the twelfth hour post-operatively, cardiac rhythm disorder, myocardial infarction, acute coronary syndrome recorded at forty-eight hours, seven days and one month post-operatively.
    - Post-operative respiratory complications occurring during the stay: respiratory infection, atelectasis, oxygen deficiency, need for mechanical ventilation or NIV, ARDS at forty-eight hours, seven days and one month post-op.
    - Infectious complications: sepsis and septic shock as defined in the international definitions (SOFA score) at forty-eight hours, seven days and one month post-op.
    - Neurological complications: altered consciousness, stroke at forty-eight hours, seven days and one month post-op.
    - Haematological complications: intraoperative blood loss, recourse to transfusion, crase disorder (decrease in prothrombin rate) at forty-eight hours, seven days and one month post-op.
    - Volume of intraoperative vascular filling with crystalloids recorded at the end of the operation
    - Mortality at 1 month
    - Assessment of the level of dependence in the activities of daily living (IADL or ADL scale at one month following discharge from hospital)
    • Durée de séjour hospitalier et durée de séjour en réanimation/unité de soins continus relevées à un mois
    • Fonction rénale postopératoire évaluée par le score KDIGO à quarante-huit heures, à sept jours et à un mois post opératoire.
    • Complications cardiovasculaires post opératoires survenant au cours du séjour : état de choc circulatoire défini par le recours aux catécholamines au-delà de la douzième heure post opératoire, trouble du rythme cardiaque, infarctus du myocarde, syndrome coronarien aigu relevées à quarante-huit heures, à sept jours et à un mois post opératoire.
    • Complications respiratoires post opératoires survenant au cours du séjour : infection respiratoire, atélectasies, oxygénoréquérance, nécessité d’une ventilation mécanique ou VNI, SDRA à quarante-huit heures, à sept jours et à un mois post opératoire.
    • Complications infectieuses : sepsis et choc septique tels que définis dans les définitions internationales (score SOFA) à quarante-huit heures, à sept jours et à un mois post opératoire.
    • Complications neurologiques : altération de la conscience, AVC à quarante-huit heures, à sept jours et à un mois post opératoire.
    • Complications hématologiques : perte sanguine per opératoire, recours à la transfusion, trouble de la crase (diminution du Taux de prothrombine) à quarante-huit heures, à sept jours et à un mois post opératoire.
    • Volume de remplissage vasculaire per opératoire par cristalloïdes relevé en fin d’intervention
    • Mortalité à 1 mois
    • Évaluation du niveau de dépendance dans les activités de la vie quotidienne (échelle IADL ou ADL à 1 mois suivant la sortie de l’hôpital)
    E.5.2.1Timepoint(s) of evaluation of this end point
    H48, day 7 and day 30
    H48, 7 jours et à 30 jours
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    prise en charge standard
    standard support
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months37
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    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
    Néant
    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 Decision2021-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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