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    Summary
    EudraCT Number:2020-004812-81
    Sponsor's Protocol Code Number:2019-48
    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:2020-11-27
    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 number2020-004812-81
    A.3Full title of the trial
    Ketamine Low dOse Evaluation on morphine consumption in traumatic patient : a prospective randomized controlled double-blind study
    Impact de la kétamine à faible dose sur l’épargne morphinique chez les patients traumatisés
    Etude prospective randomisée contrôlée en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of ketamine on opiods consumption in traumatic patient
    A.3.2Name or abbreviated title of the trial where available
    KLOE
    A.4.1Sponsor's protocol code number2019-48
    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 SponsorASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    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 supportAORC (Appel d'Offre Recherche Clinique) Assistance Publique Hôpitaux de Marseille
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressDRS, 80 rue Brochier
    B.5.3.2Town/ cityMARSEILLE
    B.5.3.3Post code13354
    B.5.3.4CountryFrance
    B.5.4Telephone number33491381594
    B.5.5Fax number33491381479
    B.5.6E-mailsophie.tardoski@ap-hm.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 KETAMINE RENAUDIN 10 mg/mL, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderRENAUDIN
    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 nameKETAMINE
    D.3.2Product code N01AX03
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETAMINE
    D.3.9.1CAS number 1867-66-9
    D.3.9.3Other descriptive nameKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Traumatism
    Traumatisme
    E.1.1.1Medical condition in easily understood language
    Traumatism
    Traumatism
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    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
    The main objective of this research is to demonstrate a significant reduction of at least 25% in the consumption of opioids at 48 hours of management of a serious trauma, while demonstrating the non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a group receiving a placebo.
    L’objectif principal de cette recherche est de mettre en évidence une diminution significative d’au moins 25% de la consommation d’opioïdes à 48 heures de prise en charge d’un traumatisme grave, tout en démontrant la non-infériorité en terme d’analgésie, dans un groupe de patients recevant une perfusion continue de kétamine à faible dose en comparaison à un groupe recevant un placebo.
    E.2.2Secondary objectives of the trial
    - Compare the cumulative doses of opioids administered during the first 5 days of treatment.
    - Compare the average VAS during the first 5 days of treatment.
    - Compare the rate of occurrence of delirium between the 2 groups occurring during intensive care.
    - Compare the rate of occurrence of complications between the 2 groups occurring during intensive care (urinary retention, nausea, vomiting, delirium, hemodynamic instability, hypertensive access, neurological distress (seizure), respiratory distress, change in liver function test )
    - Compare the average sedation times between the 2 groups in intensive care.
    - Compare the average length of stay between the 2 groups in intensive care and in the hospital.
    - Compare the rate of occurrence of chronic pain at 3 months of treatment between the 2 groups using a validated questionnaire.
    - Compare the consumption of morphine at 3 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female adult
    - Traumatized patient presenting at least 2 lesions on two different regions as defined by the ISS score (injury severity score) (Head, Thorax, Abdomen, Upper limbs, Lower limbs, Spine).
    - Patient presenting at least two regional disorders classified as moderate to maximum defined by an AIS (Abbreviated Injury Scale)> 1.
    - Patient having signed an informed consent
    -Homme ou femme majeur(e)
    -Patient traumatisé présentant au moins 2 lésions sur deux régions différentes telles que définies par le score ISS (injury severity score) (Tête, Thorax, Abdomen, Membres supérieurs, Membres inférieurs, Rachis).
    -Patient présentant au moins deux atteintes régionales classées modérées à maximales définies par un AIS (Abbreviated Injury Scale) > 1.
    -Patient ayant signé un consentement éclairé
    E.4Principal exclusion criteria
    - Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome).
    - Patient in whom the infusion could not be started within the first 6 hours of initial treatment.
    - Patient whose state of consciousness is incompatible with understanding the protocol.
    - Patient with a BMI> 35 kg / m² or a weight of more than 120 kg.
    - Patient with chronic analgesic consumption defined by consumption of opioid derivatives for more than a week for an intercurrent illness.
    - Presence of a history of chronic pain.
    - Presence of a history of epilepsy.
    - Presence of a history of psychosis or drug addiction.
    - Patients with an allergy to the molecule or excipients composing ketamine
    - Patients with an allergy to the molecule or to the excipients making up sufentanil or paracetamol.
    - Pregnant or breastfeeding woman.
    - Patient not understanding French.
    - Patients présentant une indication de sédation profonde (hypertension intracrânienne ou syndrome de détresse respiratoire aigüe).
    - Patient chez qui la perfusion ne pourrait être débutée dans les 6 premières heures de la prise en charge initiale.
    - Patient dont l’état de conscience est incompatible avec la compréhension du protocole.
    - Patient présentant un IMC > 35 kg/m² ou un poids de plus de 120 kg.
    - Patient ayant une consommation d’antalgique chronique définie par une consommation de dérivés opioïdes depuis plus d’une semaine pour une maladie intercurrente.
    - Présence d’un antécédent de douleurs chroniques.
    - Présence d’un antécédent d’épilepsie.
    - Présence d’un antécédent psychotique ou de toxicomanie.
    - Patients présentant une allergie à la molécule ou aux excipients composant la kétamine
    - Patients présentant une allergie à la molécule ou aux excipients composant le sufentanil ou le paracétamol.
    - Femme enceinte ou allaitante.
    - Patient ne comprenant pas le français.
    E.5 End points
    E.5.1Primary end point(s)
    The total dose of sufentanil administered is postponed to 48 hours of treatment by adding the doses indicated on the self-administration device and / or of the Priméa® base in the event of continuous administration with the syringe pump. All doses of sufentanil or morphine equivalents administered in the operating room during this period or during any other anesthesia procedures are added.
    In the case of oral administration, the doses of oxynorm / oxycontin administered are converted into IV morphine equivalent so that they can be counted for the primary endpoint.
    The non-inferiority character will be judged on the comparison of the mean VAS of the first 48 hours of treatment. Patients' VAS is assessed every 4 hours using a validated standardized ruler device. This systematic assessment will be offered by the registered nurse (IDE) in charge of the patient. The target given to the patient in the self-controlled administration of sufentanil will be a 30mm VAS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours
    E.5.2Secondary end point(s)
    - Cumulative dose of opioids administered during the first 5 days of treatment.
    - Average VAS during the first 5 days of treatment.
    - occurrence of delirium and quantification of nausea/vomiting and urinary retention/urinary globe.
    - occurrence of neurological distress or hemodynamic or respiratory
    - occurrence of a hepatic complication defined as an increase of more than 100% in initial bilirubin values ​​or a decrease in factor V below 50% in the absence of an explanation related to the management of the trauma or bleeding.
    - Duration of stay in intensive care unit and total length of hospitalization defined as the number of days spent between the date of admission and discharge from the intensive care unit and hospitalization.
    - amount of analgesic treatment consumed daily, the quality of life, the occurrence and quantification and location of potential chronic pain
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 days
    Total duration of stay in intensive care
    3 months
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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.8.5The 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
    - Patient died within 48 hours of treatment.
    - Patient with a hospital stay of less than 48 hours.
    - Patient requiring deep sedation during the first 48 hours except surgical management

    Otherwise, end of the study is at 3 months.
    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 months24
    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: 140
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state140
    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 Decision2021-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
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