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    Summary
    EudraCT Number:2015-004485-28
    Sponsor's Protocol Code Number:38RC15.214
    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:2015-12-03
    Trial results View 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 number2015-004485-28
    A.3Full title of the trial
    Effets d’un soluté hypertonique et du Ringer Lactate sur la fonction ventriculaire droite après chirurgie cardiaque
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Soluté hypertoniqUe en Chirurgie CardiaquE
    A.3.2Name or abbreviated title of the trial where available
    SUCCESS
    A.4.1Sponsor's protocol code number38RC15.214
    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 SponsorCentre Hospitalier Universitaire de Grenoble
    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 supportCentre Hospitalier Universitaire de Grenoble
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Universitaire
    B.5.2Functional name of contact pointDr Michel DURAND
    B.5.3 Address:
    B.5.3.1Street AddressRéanimation Cardio-vasculaire et thoracique
    B.5.3.2Town/ cityGrenoble
    B.5.3.3Post code38047
    B.5.3.4CountryFrance
    B.5.4Telephone number3304 76 76 55 10
    B.5.5Fax number3304 76 76 59 75
    B.5.6E-mailMDurand@chu-grenoble.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 No
    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 nameChlorure de sodium 7.5%
    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 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 RINGER LACTATE VIAFLO
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SAS
    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 nameRinger lactate
    D.3.2Product code B05BB01
    D.3.4Pharmaceutical form Solution for injection/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
    Patients should be operated for cardiac surgery with cardiac bypass and in sinus rhythm, and for which the fact of the existence of impaired left ventricular function or the heaviness of the surgical procedure, a decision Hemodynamic Monitoring intraoperative and postoperative by right heart catheterization is decided.
    Les patients devront être opérés d’une chirurgie cardiaque sous circulation extra corporelle, en rythme sinusal, et pour lesquels du fait de l’existence d’une altération de la fonction ventriculaire gauche ou de la lourdeur du geste opératoire, une décision de monitorage hémodynamique per et post opératoire par cathétérisme cardiaque droit est décidé.
    E.1.1.1Medical condition in easily understood language
    Patients undergoing cardiac surgery
    Patients devant subir une chirurgie cardiaque
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10061026
    E.1.2Term Cardiac operation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 the study is to assess if there is an improvement in right ventricular function after infusion of hypertonic saline compared with the effect of an isotonic solution to a similar volume expansion.
    L’objectif principal de l’étude est d’évaluer s’il y a une amélioration de la fonction ventriculaire droite après perfusion d’un soluté salé hypertonique comparé à l’effet d’un soluté isotonique permettant une expansion volémique similaire.
    E.2.2Secondary objectives of the trial
    Démontrer l’amélioration de la fonction ventriculaire gauche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age> 18 years
    - Patients undergoing coronary surgery and / or elective valvular
    - Person affiliated to the social security or receiving such a plan
    - Informed consent in writing signed by the patient or his legal representative.
    - Patients should be operated for cardiac surgery with CPB, in sinus rhythm, and for which the fact of the existence of impaired left ventricular function or the heaviness of the surgical procedure, a decision per Hemodynamic Monitoring and post operative by right heart catheterization is decided.
    - Patient requiring filling of infusion solution
    - Age > 18 ans
    - Patients devant subir une chirurgie coronaire et/ou valvulaire non urgente
    - Personne affiliée à la sécurité sociale ou bénéficiaire d’un tel régime
    - Consentement éclairé et écrit signé par le patient ou son représentant légal.
    - Les patients devront être opérés d’une chirurgie cardiaque sous CEC, en rythme sinusal, et pour lesquels du fait de l’existence d’une altération de la fonction ventriculaire gauche ou de la lourdeur du geste opératoire, une décision de monitorage hémodynamique per et post opératoire par cathétérisme cardiaque droit est décidé.
    - Patient nécessitant une perfusion de solution de remplissage
    E.4Principal exclusion criteria
    - The persons referred to in Articles 1121-5 to 1121-8 of the CSP: pregnant women, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person under a legal protection measure
    - Severe pulmonary hypertension (systolic PAP> 60 mmHg)
    - Absence of preoperative sinus rhythm
    - Emergency Surgery
    - Age <18 years
    - Renal impairment dialyzed
    - Severe Hypernatremia (symptomatic, symptomatic associated with sodium and water preoperative overload).
    - Personnes visées aux articles L1121-5 à L1121-8 du CSP: femme enceinte, parturiente, mère qui allaite, personne privée de liberté par décision judiciaire ou administrative, personne faisant l’objet d’une mesure de protection légale
    - Hypertension artérielle pulmonaire sévère (PAP systolique > 60 mmHg)
    - Absence de rythme sinusal préopératoire
    - Chirurgie en urgence
    - Age < 18 ans
    - Insuffisance rénale dialysée
    - Hypernatrémie grave (symptomatiques, associée à une surcharge hydro-sodée symptomatique pré-opératoire).
    E.5 End points
    E.5.1Primary end point(s)
    Evolution of the ejection fraction of the right ventricle measured by Swan Ganz catheterization 30 minutes and one hour after volume expansion of a hypertonic saline solution (3 ml / kg) versus Ringer lactate (10 ml / kg) .
    Evolution de la fraction d’éjection du ventricule droit mesurée par cathétérisme de Swan Ganz 30 minutes et une heure après l’expansion volémique d'une solution de sérum salé hypertonique (3 ml/kg) versus du ringer lactate (10 ml/kg).
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ringer Lactate
    Ringer Lactate
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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) No
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 2
    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 state30
    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
    Non
    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 Decision2016-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-21
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