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    Summary
    EudraCT Number:2018-003182-34
    Sponsor's Protocol Code Number:2018-10
    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:2018-08-30
    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 number2018-003182-34
    A.3Full title of the trial
    Randomized, double-blind, controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion for maintenance of hemodynamic stability during cesarean section under spinal anesthesia
    Essai clinique, contrôlé, randomisé, en double aveugle, comparant la noradrénaline à la phényléphrine en débit continu pour le maintien de l’hémodynamique au cours des césariennes programmées sous rachianesthésie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of phenylephrine versus norepinephrine for maintenance of hemodynamic during cesarean section under spinal anesthesia.
    Comparaison de la phényléphrine à la noradrénaline pour le maintien de l’hémodynamique lors de la césarienne sous rachianesthésie.
    A.3.2Name or abbreviated title of the trial where available
    PHENAD
    PHENAD
    A.4.1Sponsor's protocol code number2018-10
    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 SponsorCHR d'ORLEANS
    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 supportCHR d'ORLEANS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHR d'ORLEANS
    B.5.2Functional name of contact pointBELIN Olivier
    B.5.3 Address:
    B.5.3.1Street Address14 avenue de l'hôpital
    B.5.3.2Town/ cityORLEANS
    B.5.3.3Post code45067
    B.5.3.4CountryFrance
    B.5.4Telephone number33238514444
    B.5.5Fax number33238744364
    B.5.6E-mailolivier.belin@chr-orleans.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 MYLAN
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    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 nameNORADRENALINE
    D.3.4Pharmaceutical form Solution for infusion in administration system
    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 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 Phényléphrine RENAUDIN
    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 namePhényléphrine
    D.3.4Pharmaceutical form Solution for infusion in administration system
    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
    hypotension during caesarean section under spinal anesthesia
    hypotension au cours de l'anesthésie rachidienne pour césarienne
    E.1.1.1Medical condition in easily understood language
    hypotension during caesarean section under spinal anesthesia
    hypotension au cours de l'anesthésie rachidienne pour césarienne
    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
    The primary aim of this study is to compare prophylactic intravenous infusions of phenylephrine and noradrenaline for maintenance of cardiac output during cesarean delivery under spinal anesthesia
    Comparer la noradrénaline à la phényléphrine en débit continu sur le maintien du débit cardiaque au cours des césariennes sous rachianesthésie
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to compare effects of norepinephrine and phenylephrine in:
    -Maternal hemodynamic parameters (other than cardiac output)
    -bolus administrations of vasopressor and atropine
    -neonatal vitality assessment
    -maternal safety of experimental drugs
    -utero-placental perfusion
    -maternal blood glucose concentration
    -blood glucose concentration in the newborn.
    Comparer au cours des césariennes sous rachianesthésie l'effet de la noradrénaline par rapport à la phényléphrine
    sur :
    -les paramètres hémodynamiques maternels (autres que le débit cardiaque)
    -les bolus de vasopresseurs et d'atropine administrés
    -la vitalité du nouveau-né
    -la tolérance clinique maternelle
    -la perfusion utéro-placentaire
    -la glycémie foeto-maternelle.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Pregnancy > 36 weeks of amenorrhea
    -Scheduled or semi-urgent (interval between decision and delivery by caesarean section >12hours) caesarean section under spinal anesthesia
    -Grossesse > 36SA
    -Césarienne programmée ou semi-urgente (délai entre la décision de la césarienne et l'intervention >12h) sous rachianesthésie.
    E.4Principal exclusion criteria
    -Extreme size (<140cm,> 180cm)
    -Weight less than 50kg
    - body mass index (BMI) >40 kg/m2
    -Cardiovascular disease with use of cardiac medication
    -Active neurological disease.
    -antihypertensive drug.
    -severe pre-eclampsia
    -American Society of Anesthesiologists physical status class >3
    -Placenta accreta / percreta
    -Cesarean section scheduled under general anesthesia.
    -Contraindications to spinal anesthesia
    -age less than 18 years
    -guardianship, curatorship
    -Anemia <= 8g / dl
    -allergy to any study medication
    -simultaneous participation in another study
    -Taille extrême (<140cm ; >180 cm)
    -Poids <50kg
    -IMC>40
    - Pathologie cardio-vasculaire nécessitant un traitement
    -Pathologie neurologique évolutive.
    -Traitement anti-HTA.
    -Pré éclampsie sévère
    -ASA IV
    -Placenta accreta/percreta
    -Césarienne programmée sous anesthésie générale.
    -Contre-indications à la Rachianesthésie
    -Allergie aux drogues d'étude
    -Age < 18ans,
    -Tutelle ou curatelle
    -Anémie <= 8g/dl
    -participation à une autre étude
    E.5 End points
    E.5.1Primary end point(s)
    cardiac output (show a 12% higher cardiac output in noradrenaline versus phenylephrine group).
    Le débit cardiaque (mettre en évidence une augmentation du débit cardiaque (DC) supérieur de 12% dans le groupe noradrénaline par rapport au groupe phényléphrine)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cardiac output values were analyzed at eight points :
    -Baseline measurement : patient placed in the supine position with the table tilted 15° left, before spinal anesthesia.
    -7 measurements at regular intervals : first mesurement just after spinal anesthesia administration in supine position with the table tilted 15° left and last measurement at umbilical cord clamping.
    -Une Mesure de référence (baseline): patiente couchée en décubitus latéral gauche (DLG) de 15° juste avant la réalisation de la rachianesthésie .
    -Puis 7 mesures à intervalle régulier : la première mesure, patiente couchée en DLG de 15° immédiatement après réalisation de la rachianesthésie et la dernière mesure lors du clampage du cordon.
    E.5.2Secondary end point(s)
    -Duration of the bradycardia with Heart Rate <60 beats / minute
    -Mean blood pressure (MBP)
    -Duration of hypotension (cumulative time) with MBP <65mmhg)
    -Duration of hypotension (cumulative time) with systolic blood pressure <80mmhg)
    -Systolic Blood Pressure (SBP) in mmHg)
    -Stroke volume
    -Systemic Vascular Resistance
    -Maximum flow rate of noradrenaline and phenyleprine (ml / h)
    -Quantity of noradrenaline and phenyleprine administered (mg)
    -Quantity of corrective bolus: atropine, ephedrine (mg) and other vasopressor agent administered
    -Incidence of at least one episode of Nausea or vomiting
    -Incidence of at least one episode of dizziness or malaise
    -Maternal blood glucose level
    -Fetal well-being parameters: pH, lactate, PO2, PCO2, Base excess and glucose from umbilical artery cord blood sample. Apgar at 1min-3min-5min-10min. Capillary blood glucose measurement at 1 hour after birth.
    -Uterine and umbilical arteries doppler with measurement of the Pulsatility Index (PI) just before the realization of spinal anesthesia and 5 min after induction of spinal anesthesia.
    -Durée de la bradycardie avec fréquence cardiaque<60/min
    -variation de la pression artérielle moyenne (PAM) et durée de l'hypotension (temps cumulé) avec PAM<65mmhg
    -variation de la pression artérielle systolique (PAS) et durée de l'hypotension (temps cumulé) avec PAS<80mmhg
    -Volume d'Ejection Systémique
    -Résistances Vasculaires Systémiques
    -Débit maximum du vasopresseur d'étude (ml/h)
    -Quantité du vasopresseur d'étude administrée (mg)
    -Quantité de bolus correcteur, d'atropine, d'éphédrine (mg) et d'autres vasopresseurs administrée
    -Survenue d'au moins un épisode de Nausée ou vomissement
    -Survenue d'au moins un épisode de vertiges ou de sensation de malaise
    -Glycémie maternelle mesurée à la pose de la perfusion et au clampage du cordon par glycémie capillaire.
    -Paramètres de bien-être foetal : pH, lactate, PO2, PCO2, Base excess et glycémie au cordon, Apgar à 1min-3min-5min 10min. glycémie capillaire à H1 (sauf si mère diabétique).
    -Doppler des artères, utérines et ombilicales, avec mesure de l'Index de Pulsatilité (IP) juste avant la réalisation de la rachianesthésie puis 5min après induction de la rachianesthésie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Maternal blood glucose measurements at peripheral intravenous line placement and umbilical cord clamping
    -Fetal well-being parameters: pH, lactate, PO2, PCO2, Base excess and glucose from umbilical artery cord blood sample. Apgar at 1min-3min-5min-10min. Capillary blood glucose measurement at 1 hour after birth.
    -Uterine and umbilical arteries doppler with measurement of the Pulsatility Index (PI) just before the realization of spinal anesthesia and 5 min after induction of spinal anesthesia.
    -hemodynamic monitoring: measurement frequency, every 1 minute from induction of spinal anesthesia until umbilical cord clamping and after every 3 minutes until weaning of vasopressor
    -others Secondary end points : data collection from spinal anesthesia induction until weaning of vasopressor
    -Glycémie maternelle mesurée à la pose de la perfusion et au clampage du cordon par glycémie capillaire.
    -Paramètres de bien-être foetal : pH, lactate, PO2, PCO2, Base excess et glycémie au cordon, Apgar à 1min-3min-5min 10min. glycémie capillaire à H1 (sauf si mère diabétique).
    -Doppler des artères, utérines et ombilicales, avec mesure de l'Index de Pulsatilité (IP) juste avant la réalisation de la rachianesthésie puis 5min après induction de la rachianesthésie.
    -pour tous les autres critères : recueil des informations de induction de la rachianesthésie jusqu’au sevrage du vasopresseur et mesures hémodynamiques toutes les 1 min de l’induction de la rachianesthésie jusqu'au clampage du cordon, puis toutes les 3 min jusqu’au sevrage du vasopresseur
    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 Yes
    E.6.4Safety Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) 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 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 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
    LVLS
    L'étude se termine après l'inclusion de la dernière patiente
    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 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: 124
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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 state124
    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)
    No plan for treatment related to the strial
    Pas de modification du traitement dans le cadre d'un protocole de soin
    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 Decision2018-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-02
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