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    Summary
    EudraCT Number:2017-005144-14
    Sponsor's Protocol Code Number:01-CARDIONIDO
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-04-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-005144-14
    A.3Full title of the trial
    Comparative study of two types of cardioplegia during cardiac surgery in the adult patient
    Estudio comparativo de dos tipos de cardioplejia durante la cirugía cardiaca en el paciente adulto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative study of two types of cardioplegia during cardiac surgery in the adult patient
    Estudio comparativo de dos tipos de cardioplejia durante la cirugía cardiaca en el paciente adulto
    A.3.2Name or abbreviated title of the trial where available
    CARDIONIDO
    CARDIONIDO
    A.4.1Sponsor's protocol code number01-CARDIONIDO
    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 SponsorDr. Forteza Gil
    B.1.3.4CountrySpain
    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 supportDr. Fortaleza Gil
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDra. Jessica García Suárez
    B.5.2Functional name of contact pointDra. Jessica García Suárez
    B.5.3 Address:
    B.5.3.1Street AddressC/ Joaquín Rodrigo nº 2
    B.5.3.2Town/ cityMajadahonda- Madrid
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number+34660 164 436
    B.5.6E-mailjessicag.suarez@gmail.com
    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 namedel Nido Cardioplegic solution
    D.3.4Pharmaceutical form Solution for cardioplegia
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM BICARBONATE BP
    D.3.9.3Other descriptive nameSODIUM BICARBONATE BP
    D.3.9.4EV Substance CodeSUB169196
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMAGNESIUM SULFATE
    D.3.9.1CAS number 7487-88-9
    D.3.9.3Other descriptive nameMAGNESIUM SULFATE
    D.3.9.4EV Substance CodeSUB14448MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mol/l mole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMANNITOL
    D.3.9.3Other descriptive nameMANNITOL
    D.3.9.4EV Substance CodeSUB03087MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOTASSIUM CHLORIDE
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mol/l mole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE
    D.3.9.3Other descriptive nameLIDOCAINE
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPLASMALYTE
    D.3.9.3Other descriptive namePLASMALYTE-A
    D.3.9.4EV Substance CodeSUB118335
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Cardi-Braun Cardioplegic Solution
    D.2.1.1.2Name of the Marketing Authorisation holderBRAUN MEDICAL, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for cardioplegia
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary 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
    Cardiac surgery
    Cirugía cardíaca
    E.1.1.1Medical condition in easily understood language
    Cardiac surgery
    Cirugía cardíaca
    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
    Assess prospectively the two types of cardioplegia used regularly in our Center.
    Valorar de forma prospectiva las dos tipos de cardioplejia utilizados de forma habitual en nuestro Centro.
    E.2.2Secondary objectives of the trial
    Record and assess the clinical data and complications associated with the treatment.
    Registrar y analizar los datos clínicos y complicaciones asociadas al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients over 18 years of age.
    • Patients undergoing scheduled surgery under extracorporeal circulation.
    • Patients who, after receiving information about the study, authorize their participation in writing.
    • Pacientes mayores de 18 años.
    • Pacientes sometidos a cirugía programada bajo circulación extracorpórea.
    • Pacientes que tras haber recibido información sobre el estudio, autoricen por escrito su participación.
    E.4Principal exclusion criteria
    • Patients under 18 years of age.
    • Patients who do not consent to participate in the study.
    • Documented allergy to amide-type local anesthetics.
    • Emergent surgery. It includes:
    --- Surgery: cardiac transplant, aortic dissection, endocarditis, shock code.
    --- Regardless of the type of surgical intervention, all those unstable patients who require pharmacological inotropic support, mechanical support (BCIAO, ECMO) or preoperative intubation.
    • Patients undergoing surgery scheduled under a minimally invasive Heart Port procedure.
    • Pacientes menores de 18 años.
    • Pacientes que no consientan participar en el estudio.
    • Alergia documentada a anestésicos locales tipo amida.
    • Cirugía emergente. Incluye:
    ---Cirugía de: trasplante cardiaco, disección aórtica, endocarditis, Código shock.
    ---Independientemente del tipo de intervención quirúrgica, todos aquéllos pacientes inestables que precisan soporte inotrópico farmacológico, soporte mecánico (BCIAO, ECMO) o intubación preoperatoria.
    • Pacientes sometidos a cirugía programada bajo procedimiento mínimamente invasivo Heart Port.
    E.5 End points
    E.5.1Primary end point(s)
    Acute cardiovascular event (Yes / No). Composite variable formed by one or more of the following events:
    • Early perioperative infarction (first 72 hours after surgery). Defined according to the criteria of the Working Team of the European Society of Cardiology, the AHA (American Heart Association) and the WHF (World Heart Federation), as the elevation of cardiac biomarkers (troponin T, CK) 10 times the 99th percentile of the normal reference value, together with at least one of the following parameters:
    --- Appearance of new waves Q.
    --- Appearance of a new left branch block.
    --- Angiographic evidence of new occlusion of native vessels or grafts.
    --- Alterations of contractility detected by ETT or TEE not present before surgery.
    • Prolonged low cardiac output. Defined as the need to maintain support with two or more inotropic drugs and / or other circulatory mechanical assistance devices (BCIAo, ECMO) at 24 h postoperatively.
    • Appearance of arrhythmias (TV / FV) requiring CVE in the first 24 hours postoperatively.
    Evento cardiovascular agudo (Sí/No). Variable compuesta formada por uno o más de los siguientes eventos:
    • Infarto perioperatorio precoz (primeras 72 horas tras la cirugía). Definido de acuerdo con los criterios del Equipo de Trabajo de la Sociedad Europea de Cardiología, la AHA (American Heart Association) y la WHF (World Heart Federation), como la elevación de biomarcadores cardiacos (troponina T, CK) 10 veces el percentil 99 del valor normal de referencia, junto con al menos uno de los siguientes parámetros:
    ---Aparición de nuevas ondas Q.
    ---Aparición de un nuevo bloqueo de rama izquierda.
    ---Evidencia angiográfica de nueva oclusión de los vasos nativos o los injertos.
    ---Alteraciones de la contractilidad detectadas por ETT o ETE no presentes antes de la cirugía.
    • Bajo Gasto Cardiaco prolongado: Definido como la necesidad de mantener soporte con dos o más inotrópicos y/o otros dispositivos de asistencia mecánica circulatoria (BCIAo, ECMO) a las 24 hrs de postoperatorio.
    • Aparición de arritmias (TV/FV) que precisen CVE en las primeras 24 horas de postoperatorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim analysis planned on October 2018 (indicative date).
    Final analysis planned on June 2019.
    Análisis intermedio previsto en octubre 2018 (fecha orientativa).
    Análisis final previsto en junio 2019.
    E.5.2Secondary end point(s)
    • Need for electrical cardioversion (Yes / No).
    • Number of electrical Cardioversion required.
    • Use of intraoperative antiarrhythmics drugs.
    • Postoperative AF appearance (Yes / No).
    • Requirement of inotropic pharmacological support. Time until the total withdrawal of the inotropic support.
    • Intraoperative and postoperative blood transfusion.
    • Acute kidney failure. Defined by KDIGO scale.
    • Postoperative sepsis (Yes / No). Defined according to current guidelines (SOFA).
    • Postoperative pneumonia (Yes / No). Defined as the appearance of a pulmonary infiltrate and at least one of the following criteria: fever, leukocytosis, positive respiratory cultures.
    • Seizure activity (Yes / No): Defined as the appearance of tonic-clonic movements and / or the appearance of epileptiform electrical activity in EEG.
    • Stroke (ACVA) (Yes / No). Defined as the development of focal or global signs of brain function compromise, with symptoms lasting 24 hours or more, as evidenced by cranial CT or brain MRI.

    Additional efficacy and safety variables.
    • Ischemia time (min).
    • Perfusion time (min).
    • Volume of administered cardioplegic solution (ml).
    • Route of administration (Anterograde / retrograde / dual).
    • Reperfusion solution administration (Yes / No).
    • Time from the administration of cardioplegia to the electromechanical stop of the heart.
    • Value of Troponins and CK upon arrival at ICU and at 24 hours of stay. Maximum peak of Troponins and CK in the first 24 hours postoperatively.
    • Hemoglobin value upon arrival at ICU and at 24 hours of stay.
    • Mechanical ventilation time from admission in ICU to extubation (min).
    • Need for renal replacement therapy (CRRT, HD).
    • Need for re-entry in ICU (Yes / No).
    • Time of stay in ICU and hospital (Days).
    • Left ventricular ejection fraction at hospital discharge.
    • Mortality (Yes / No). Survival at 30 days.
    • Disaggregated costs of the cardioplegic solution (price / bag).
    • Costs related to the time of stay in ICU and time of hospital stay.
    • Necesidad de Cardioversión eléctrica del corazón tras la salida de isquemia (Sí/No).
    • Número de Cardioversiones eléctricas requeridas.
    • Uso de antiarrítmicos intraoperatorios.
    • Aparición de FA postoperatoria (Sí/No).
    • Requerimiento de soporte farmacológico inotrópico. Tiempo hasta la retirada total del soporte inotrópico.
    • Transfusión sanguínea intraoperatoria y postoperatoria.
    • Insuficiencia renal aguda. Definida por escala KDIGO.
    • Sepsis postoperatoria (Sí/No). Definida según Guías actuales (SOFA).
    • Neumonía postoperatoria (Sí/No). Definida como la aparición de un infiltrado pulmonar y al menos uno de los siguientes criterios: fiebre, leucocitosis, cultivos respiratorios positivos.
    • Actividad convulsiva (Sí/No): Definida como la aparición de movimientos tonico-clónicos y/o la aparición de actividad eléctrica epileptiforme en EEG.
    • Accidente cerebrovascular (ACVA) (Sí/No). Definido como el desarrollo de signos focales o globales de compromiso de la función cerebral, con síntomas de 24 horas o más de duración, constatado a través de TC craneal o RM cerebral.

    Variables adicionales de eficacia y seguridad.
    • Tiempo de isquemia (min).
    • Tiempo de perfusión (min).
    • Volumen de solución cardioplejica administrada (ml).
    • Vía de administración (Anterógrada/ retrógrada/ dual).
    • Administración de solución de reperfusión (Sí/No).
    • Tiempo desde la administración de la cardioplejia hasta la parada electromecánica del corazón.
    • Valor de Troponinas y CK a la llegada a UCPQ y a las 24 horas de estancia. Pico máximo de Troponinas y CK en las primeras 24 horas de postoperatorio.
    • Valor de Hemoglobina a la llegada a UCPQ y a las 24 horas de estancia.
    • Tiempo de Ventilación mecánica desde el ingreso en UCPQ hasta la extubación (min).
    • Necesidad de terapia renal sustitutiva (TRRC, HD).
    • Necesidad de reingreso en UCPQ (Sí/No).
    • Tiempo de estancia en UCPQ y hospitalaria (Días).
    • Fracción de eyección de Ventrículo izquierdo al alta hospitalaria.
    • Mortalidad (Sí/No). Supervivencia a los 30 días.
    • Costes desglosados de la solución cardiopléjica (precio/bolsa).
    • Costes relativos al tiempo de estancia en UCPQ y tiempo de estancia hospitalario.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim analysis planned on October 2018 (indicative date).
    Final analysis planned on June 2019.
    Análisis intermedio previsto en octubre 2018 (fecha orientativa).
    Análisis final previsto en junio 2019.
    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 Yes
    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
    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 months15
    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: 474
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 474
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    As long as an authorized legal representative signs the Informed Consent.
    Siempre y cuando firme el Documento de Consentimiento Informado un representante legal autorizado.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state474
    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
    Ninguno
    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 Decision2018-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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