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    Summary
    EudraCT Number:2015-005685-30
    Sponsor's Protocol Code Number:2015-005685-30
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-005685-30
    A.3Full title of the trial
    Evaluation of microcirculation alterations in cardiac surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and biological analysis
    Evaluation des altérations de la microcirculation en chirurgie cardiaque par FMD (Flow Mediated vasoDilation), Spectrophotométrie infrarouge (NIRS) et analyse biologique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of corticoids on microcirculation in cardiac surgery
    L'effet des corticoïdes sur la microcirculation en chirurgie cardiaque
    A.3.2Name or abbreviated title of the trial where available
    SICS
    A.4.1Sponsor's protocol code number2015-005685-30
    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 SponsorHôpital Erasme
    B.1.3.4CountryBelgium
    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 supportHôpital Erasme
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Erasme
    B.5.2Functional name of contact pointAnesthésie
    B.5.3 Address:
    B.5.3.1Street Address808 Route de Lennik
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.6E-mailkatarina.halenarova@erasme.ulb.ac.be
    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 Solu - Medrol 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameSolu - Medrol 500mg
    D.3.2Product code H02AB04
    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.3.8INN - Proposed INN277 S 102 F12
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM SUCCINATE
    D.3.9.4EV Substance CodeSUB14562MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboInjection
    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
    Cardiac pathology eligible for surgery
    Pathologie cardiaque programmée pour chirurgie cardiaque
    E.1.1.1Medical condition in easily understood language
    cardiac condition needing a surgery with CBP
    maladie cardiaque nécessitant intervention chirurgicale avec CEC
    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
    Evaluate the effect of corticoids versus NaCl on microcirculation in
    cardiac surgery with CBP
    Evaluation des effets des corticoïdes sur la microcirculation en chirurgie cardiaque avec CEC
    E.2.2Secondary objectives of the trial
    Not applicable
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    all patients eligible for cardiac surgery with CBP
    Tous les patients candidats de chirurgie cardiaque avec CEC
    E.4Principal exclusion criteria
    Age under 18years
    Allergy to corticoids
    Extreme emergency surgery
    Impossibility of pneumatic cuff placement on upper limb
    Age en dessous de 18 ans Allergie aux corticoïdes
    Chirurgie d'extrême urgence
    Impossibilité de placer un garrot au membre supérieur
    E.5 End points
    E.5.1Primary end point(s)
    Variation of diameter of brachial artery and peripheral StO2 variation:
    A/ FMD (Flow Mediated vasoDilation) which is a non invasive technique considered as the gold standard for endothelial reactivity evaluation since the end of 1990s. It is based on echographic measurement of brachial artery diameter variation and the Doppler flow evaluation, during an episode of transient ischemia induced by pneumatic cuff inflation (vascular occlusion test).
    Some studies showed a reversible alteration of endothelial function mainly after cardiac surgery using CBP with continuous blood flow (FMD variation of about 11%). We are expecting a reduction of endothelial dysfunction with corticoids by 5%, In previous studies, variation is already significative when FMD varies from 1,5 – 2%.
    B/ NIRS (near infrared spectroscopy) – it’s a non invasive technique which measures peripheral tissue oxygen saturation and allows to assess oxygen consumption and microcirculation reactivity during an arterial occlusion test distally to compressive cuff.
    Alterations of the variables derived from delta StO2 (peripheral tissue oxygen saturation) after an ischemic – reperfusion event, rather than absolute value of StO2 are predictive of bad prognosis in a septic patient or in severe head injury. These variables are delta StO2, HbT (total tissue hemoglobin) and THI (muscular hemoglobin index). From these elements can be calculated others: RdecStO2 (StO2 decrease rate during ischemic event reflecting the tissue oxygen consumption) and RincStO2 (increase rate of StO2 during the reperfusion phase, corresponding to relative hyperemia). Both are expressed in %/s. The intensity of reperfusion can be quantified by delta THI.
    A recent study in cardiac surgery did not show StO2 modifications under CBP but providing a small population sample and the type of monitoring used, this study might include some methodologic biais. Finally, very recently a correlation between FMD and the variation of NIRS during a vascular occlusion test has been found in a young healthy subject, which only confirms the influence of endothelial function onto microcirculation.
    variation du diamètre de l'artère brachiale et StO2 périphérique:
    A/ Le FMD (Flow Mediated vasoDilation) qui est la technique non invasive considérée comme la référence pour l’étude de la réactivité endothéliale depuis la fin des années 90. Ce monitoring se base sur la mesure de la variation du diamètre de l’artère brachiale par échographie ainsi que la vitesse du flux dans cette artère par Doppler, après une ischémie transitoire de 5 minutes induite par le gonflement d’un garrot placé distalement sur l’avant – bras (test d’occlusion). Plusieurs études ont déjà démontré une altération réversible de la fonction endothéliale essentiellement après chirurgie sous CEC utilisant une pompe a flux continu (11%). Nous nous attendons à un effet de réduction de la dysfonction endothéliale par les corticoïdes de 5%, nous allons analyser un groupe de 60 patients dont 30 dans le groupe Corticoïdes et 30 dans le groupe contrôle.
    B/ Le NIRS (near infrared spectroscopy) – c’est une technique non invasive de mesure de la saturation tissulaire en 02 qui, lors d’un test d’occlusion artériel, permet de mesurer la consommation d’oxygène et la réactivité de la microcirculation distalement au garrot. Les altérations des variables dérivées du changement de la StO2 (saturation tissulaire en O2) après une manœuvre d’ischémie – reperfusion, plutôt que la valeur de StO2 au repos, sont associées à un mauvais pronostic du patient septique ou traumatisé crânien. Tout récemment, une corrélation entre le FMD et la variation du NIRS lors d’un test d’occlusion chez un sujet jeune en bonne santé a été démontrée, ce qui confirme l’influence de la fonction endothéliale sur la microcirculation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The day before surgery, at ICU admission, at 24hours and at 7th day
    La veille de la chirurgie, à l'admission à l'USI, à 24h et au J7
    E.5.2Secondary end point(s)
    C/ Syndecan – 1 concentration assessment: This molecule is closely linked to glycocalyx and is considered as the most predictive marker of its integrity.
    Many factors might cause lesions of this structure (inflammation, hyperglycemia, CBP, etc). Its destruction causes further an impairement of endothelial function (vasoconstriction et vasodilation), mediated principally by endothelial factors.
    Corticoids can be considered as the most effective molecule for glycocalyx protection.
    Yet we will analyze syndecan - 1 as a glycocalyx marker, then endothelial markers (facteur de von Willebrandt ) and inflammation markers (CRP).
    C/ Le dosage de la variation en syndécan 1: Cette molécule qui est étroitement liée au glycocalyx (surface protectrice de l’endothélium) est considérée comme le marqueur le plus fiable de la perte de son intégrité. De nombreux facteurs peuvent engendrer des lésions de cette structure (inflammation, hyperglycémie, CEC, etc). Sa destruction entraîne une altération de la fonction endothéliale (vasoconstriction et vasodilatation) qui est médiée principalement par les facteurs endothéliaux. Les corticoïdes représentent actuellement les molécules les plus efficaces pour la protection du glycocalyx. Nous allons doser le syndecan 1 et secondairement les marqueurs d’endothélium (facteur de von Willebrandt et que les marqueurs de l’inflammation dont la CRP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The day before surgery, at anesthesia induction, at ICU admission, at 24 and 48 hours
    La veille de la chirurgie, à l'induction d'anesthésie, à l'admission à l'USI, à 24h et à 48h
    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) 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) 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
    LVLS
    LVLS
    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 months
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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
    Aucun
    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 Decision2016-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-08-09
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