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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-023093-39
    Sponsor's Protocol Code Number:IIBSP-EST-2011-35
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-09
    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 number2010-023093-39
    A.3Full title of the trial
    Ensayo clínico aleatorizado y doble ciego, controlado con placebo, de esteroides perioperatorios en pacientes adultos de alto riesgo sometidos a cirugía cardiaca con circulación extracorpórea (CEC)
    Ensayo clínico aleatorizado y doble ciego, controlado con placebo, de esteroides perioperatorios en pacientes adultos de alto riesgo sometidos a cirugía cardiaca con circulación extracorpórea (CEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Steroids In caRdiac Surgery Trial
    Steroids In caRdiac Surgery Trial
    A.3.2Name or abbreviated title of the trial where available
    SIRS Trial
    SIRS Trial
    A.4.1Sponsor's protocol code numberIIBSP-EST-2011-35
    A.5.4Other Identifiers
    Name:CIHR Reference NumberNumber:MOP106460
    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 SponsorInstitut de Recerca Hospital Sant Pau
    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 supportCanadian Institutes of Health Research (CIHR)
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Hospital Sant Pau
    B.5.2Functional name of contact pointRomy Rodriguez
    B.5.3 Address:
    B.5.3.1Street AddressC. Sant Antoni Mª Claret, 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number00349329190001969
    B.5.5Fax number0034935537812
    B.5.6E-mailRRodriguezMu@santpau.cat
    D. IMP Identification
    D.IMP: 1
    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.2.5The 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 nameMethylprednisolone sodium succinate
    D.3.4Pharmaceutical form Powder for solution for 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 INNmethylprednisolone
    D.3.9.1CAS number 03/03/2375
    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 placeboSolution for injection
    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
    adult patients with coronary artery disease and/or valvular disease
    requiring cardiac surgery with the use of cardiopulmonary bypass.
    pacientes adultos de alto riesgo sometidos a cirugía cardiaca con circulación extracorpórea (CEC).
    E.1.1.1Medical condition in easily understood language
    adult patients with heart disease needing open-heart surgery with the
    use of heart-lung machine
    pacientes adultos de alto riesgo sometidos a cirugía cardiaca con circulación extracorpórea (CEC).
    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
    The primary objective:
    The primary objective of this study is to evaluate if methylprednisolone
    given before cardiopulmonary bypass reduces 30-day all-cause
    mortality in high-risk patients.
    El objetivo principal de este estudio es evaluar si metilprednisolona administrada antes de la circulación extracorpórea reduce la mortalidad por cualquier causa a los 30 días en pacientes de alto riesgo.
    E.2.2Secondary objectives of the trial
    Most Important Secondary Objective:
    1. To evaluate if methylprednisolone given before cardiopulmonary
    bypass reduces 30-day all-cause mortality or significant myocardial
    injury in high-risk patients
    Secondary Objectives
    2. To evaluate if methylprednisolone given before cardiopulmonary
    bypass reduces 6-month all-cause mortality in high-risk patients
    3. To evaluate if methylprednisolone given before cardiopulmonary
    bypass reduces postoperative morbidity related to atrial fibrillation,
    bleeding, delirium, blood transfusions, and length of stay in high-risk
    patients
    4. To evaluate the safety of methylprednisolone. Assessment of the
    impact on infections, gastrointestinal, and wound complications.
    1. Evaluar si metilprednisolona administrada antes de la circulación extracorpórea disminuye la mortalidad por cualquier causa a los 30 días o el daño miocárdico significativo en pacientes de alto riesgo.
    2. Evaluar si metilprednisolona administrada antes de la circulación extracorpórea reduce la mortalidad por cualquier causa a los 6 meses en pacientes de alto riesgo.

    3 Evaluar si metilprednisolona administrada antes de la circulación extracorpórea reduce la morbilidad perioperatoria asociada a fibrilación auricular, sangrado, delirio, transfusiones sanguíneas y duración de la hospitalización en pacientes de alto riesgo.

    4 Evaluar la seguridad de metilprednisolona. Evaluación del impacto sobre la tasa de infecciones, complicaciones gastrointestinales y de la herida quirúrgica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age more or equal to 18 years
    2. Require CPB for any cardiac surgical procedure (such as CABG,
    Valve, Aorta, or combined procedures)
    3. EuroScore greater than or equal to 6
    4. Written informed consent
    1) Edad ? 18 años
    2) CEC para cualquier procedimiento quirúrgico cardíaco
    3) Puntuación global del Euroscore ? 6
    4) Consentimiento informado
    E.4Principal exclusion criteria
    1. Use of systemic steroids or will undergo planned systemic steroid
    therapy in the immediate postoperative period (e.g. cardiac
    transplantation)
    2. History of bacterial or fungal infection in the last 30 days
    3. Allergy or intolerance to corticosteroids
    4. Receiving Aprotinin
    5. Previous participation in this study
    1) Uso de esteroides sistémicos o pacientes que necesitarán corticoides sistémicos en el periodo postoperatorio inmediato (ej: transplante cardíaco)
    2) Antecedentes de infección bacteriana o fúngica en los últimos 30 días
    3) Alergia o intolerancia a los corticosteroides
    4) En tratamiento con Aprotinina
    5) Participación previa en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    30-Day post-surgery all-cause mortality
    Mortalidad por cualquier causa a los 30 días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point, all-cause mortality, will be evaluated 30 days
    after surgery.
    Incidencia de muerte por cualquier causa o daño miocárdico mayor a los 30 días.
    E.5.2Secondary end point(s)
    The incidence of a composite of significant myocardial injury or death
    at 30 days is the most important secondary end point.
    All-cause mortality at 6 months, new onset atrial fibrillation,
    transfusion requirements, bleeding (chest tube output 24 hour),
    duration of mechanical ventilation, length of ICU stay and hospital
    stay.
    Infection, delirium, stroke, wound complication, GI hemorrhage, GI
    perforation, postoperative insulin use and peak blood glucose during
    the first 24 hours after surgery.
    Resultado Secundario más importante
    Incidencia de muerte por cualquier causa o daño miocárdico mayor a los 30 días.
    Otros resultados de eficacia:
    Mortalidad por cualquier causa a los 6 meses, nuevo episodio de fibrilación auricular, transfusiones sanguíneas, sangrado (drenaje torácico a las 24 horas), duración de la ventilación mecánica, duración del ingreso en UCI y duración de la hospitalización.

    Resultados de Seguridad
    Infección, delirio, accidente vascular, complicaciones de la herida, hemorragia gastrointestinal, perforación gastrointestinal, uso de insulina en el postoperatorio y glicemia máxima en las primeras 24 horas postoperatorias.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The most important secondary end point will be evaluated 30 days
    after surgery.
    Other efficacy and safety end points will be evaluated at all visits after
    surgery (at the ICU visit (i.e. 24 hours post-operatively), at the
    discharge visit, at the 30-day and 6-month follow up visits).
    Resultado Secundario más importante
    Incidencia de muerte por cualquier causa o daño miocárdico mayor a los 30 días.
    Eficacia y seguridad End points, serán evaluados despues de la operación (en la visita a las 24 horas (UCI), en la vista a los 30 días y en la visita de seguimiento a los 6 meses.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Colombia
    Czech Republic
    Greece
    Hungary
    India
    Iran, Islamic Republic of
    Ireland
    Italy
    South Africa
    Spain
    United States
    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
    El investigador y/o el paciente podrán decidir la salida prematura del estudio si lo creen conveniente. En este caso el paciente será tratado seguiendo la práctica habitual de su patologia
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years4
    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) Yes
    F.1.2.1Number of subjects for this age range: 3000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4500
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1160
    F.4.2.2In the whole clinical trial 7500
    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)
    Treatment or care after the subject has ended the participation in the trial will not be different from the expected normal treatment of that condition.
    El tratamiento o cuidados después que el sujeto ha terminado la participación en el ensayo clínico no será diferente del tramiento normal esperado para su estado.
    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 Decision2012-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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