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    Summary
    EudraCT Number:2016-003906-16
    Sponsor's Protocol Code Number:DESEVAR
    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:2017-01-10
    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 number2016-003906-16
    A.3Full title of the trial
    FAST-TRACK IN ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH DESFLURANE AND SEVOFLURANE: A RANDOMIZED CLINICAL TRIAL
    FAST-TRACK EN LA REPARACIÒN ENDOVASCULAR DEL ANEURISMA DE AORTA CON DESFLURANO Y SEVOFLURANO: ENSAYO CLÍNICO RANDOMIZADO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH DESFLURANE AND SEVOFLURANE
    REPARACIÒN ENDOVASCULAR DEL ANEURISMA DE AORTA CON DESFLURANO Y SEVOFLURANO: ENSAYO CLÍNICO RANDOMIZADO.
    A.4.1Sponsor's protocol code numberDESEVAR
    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 SponsorBegoña Quintana
    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 supportBAXTER Grant “Anesthesia and Critical Care”-
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBegoña Quintana
    B.5.2Functional name of contact pointBegoña Quintana
    B.5.3 Address:
    B.5.3.1Street AddressC/ Doctor Esquerdo, 46
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.6E-mailbegoquinti@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 Yes
    D.2.1.1.1Trade name SUPRANE
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER
    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 Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESFLURANE
    D.3.9.1CAS number 57041-67-5
    D.3.9.4EV Substance CodeSUB06993MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 sevorane
    D.2.1.1.2Name of the Marketing Authorisation holderAbbvie
    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.3.1Product namesevorane
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSEVOFLURANE
    D.3.9.1CAS number 28523-86-6
    D.3.9.2Current sponsor codeSEVOFLURANE
    D.3.9.3Other descriptive nameSEVOFLURANE
    D.3.9.4EV Substance CodeSUB10506MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    AORTIC ANEURYSM
    aneurisma aortico
    E.1.1.1Medical condition in easily understood language
    AORTIC ANEURYSM
    aneurisma aortico
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level HLT
    E.1.2Classification code 10002889
    E.1.2Term Aortic aneurysms and dissections
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    comparar el efecto de dos fármacos, desflurano y sevoflurano, en la función renal en los pacientes sometidos a cirugía de reparación endovascular de aneurisma de aorta
    comparar el efecto de dos fármacos, desflurano y sevoflurano, en la función renal en los pacientes sometidos a cirugía de reparación endovascular de aneurisma de aorta
    E.2.2Secondary objectives of the trial
    comparar entre ambos fármacos (i) Tiempo despertar (apertura ojos, responde órdenes, orientación), (ii) Tiempo extubación, (iii) recuperación postanestésica, (iv) Tiempo de estancia en la Unidad de Reanimación y (v) Tiempo ventilación mecánica controlada en postoperatorio en los dos grupos del estudio.
    comparar entre ambos fármacos (i) Tiempo despertar (apertura ojos, responde órdenes, orientación), (ii) Tiempo extubación, (iii) recuperación postanestésica, (iv) Tiempo de estancia en la Unidad de Reanimación y (v) Tiempo ventilación mecánica controlada en postoperatorio en los dos grupos del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    paciente con o mayor de 18 años que va a ser intervenido de cirugía programada de reparación endovascular de aneurisma de aorta, y ha firmado el consentimiento informado.
    paciente con o mayor de 18 años que va a ser intervenido de cirugía programada de reparación endovascular de aneurisma de aorta, y ha firmado el consentimiento informado.
    E.4Principal exclusion criteria
    Hipersensibilidad conocida a alguno de los agentes anestésicos (desflurano, sevoflurano), cualquiera de las contraindicaciones recogidas en la Ficha Técnica autorizadas para Sevoflurano y Desflurano
    Hipersensibilidad conocida a alguno de los agentes anestésicos (desflurano, sevoflurano), cualquiera de las contraindicaciones recogidas en la Ficha Técnica autorizadas para Sevoflurano y Desflurano
    E.5 End points
    E.5.1Primary end point(s)
    Cistatina C, Creatinina, Na, K, Cl, albúmina, osmolaridad, MDA, NGAL y KIM1, glucosa, hemoglobina y hematocrito en plasma. Creatinina, Na, K, Cl, osmolaridad, glucosa, albúmina, NGAL, KIM1 y H2O2 en orina.
    Cistatina C, Creatinina, Na, K, Cl, albúmina, osmolaridad, MDA, NGAL y KIM1, glucosa, hemoglobina y hematocrito en plasma. Creatinina, Na, K, Cl, osmolaridad, glucosa, albúmina, NGAL, KIM1 y H2O2 en orina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    (i) Basal (pre-cirugía), (ii) Al finalizar la cirugía, (III) tras 24h post-cirugía.
    (i) Basal (pre-cirugía), (ii) Al finalizar la cirugía, (III) tras 24h post-cirugía.
    E.5.2Secondary end point(s)
    Tiempo extubación, apertura de ojos, respuesta a órdenes y orientación tras la suspensión del fármaco. Test de recuperación postanestésica (escala de Aldrete) terminada la cirugía y en la reanimación .
    Tiempo de ventilación mecánica controlada tras la cirugía.
    Tiempo de estancia en la Unidad de Reanimación.
    Otras: tiempo de cirugía, tiempo de anestesia, cantidad de contraste administrado (ml).
    Tiempo extubación, apertura de ojos, respuesta a órdenes y orientación tras la suspensión del fármaco. Test de recuperación postanestésica (escala de Aldrete) terminada la cirugía y en la reanimación .
    Tiempo de ventilación mecánica controlada tras la cirugía.
    Tiempo de estancia en la Unidad de Reanimación.
    Otras: tiempo de cirugía, tiempo de anestesia, cantidad de contraste administrado (ml).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tiempo extubación, apertura de ojos, respuesta a órdenes y orientación tras la suspensión del fármaco. Test de recuperación postanestésica (escala de Aldrete) terminada la cirugía y en la reanimación .
    Tiempo de ventilación mecánica controlada tras la cirugía.
    Tiempo de estancia en la Unidad de Reanimación.
    Otras: tiempo de cirugía, tiempo de anestesia, cantidad de contraste administrado (ml).
    Tiempo extubación, apertura de ojos, respuesta a órdenes y orientación tras la suspensión del fármaco. Test de recuperación postanestésica (escala de Aldrete) terminada la cirugía y en la reanimación .
    Tiempo de ventilación mecánica controlada tras la cirugía.
    Tiempo de estancia en la Unidad de Reanimación.
    Otras: tiempo de cirugía, tiempo de anestesia, cantidad de contraste administrado (ml).
    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 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 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
    last patient last visit
    ultima visita del último paciente
    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 months6
    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) No
    F.1.3.1Number of subjects for this age range: 20
    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 state80
    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 Decision2017-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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