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    Summary
    EudraCT Number:2017-003027-30
    Sponsor's Protocol Code Number:IIBSP-ALB-2017-72
    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:2017-09-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-003027-30
    A.3Full title of the trial
    Influence of albumin on the development of acute renal dysfunction associated with cardiac surgery under extracorporeal circulation
    Influencia de la Albúmina en el desarrollo de la disfunción renal aguda asociada a la cirugía cardiaca bajo circulación extracorpórea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of albumin on the development of acute renal dysfunction associated with cardiac surgery under extracorporeal circulation
    Influencia de la Albúmina en el desarrollo de la disfunción renal aguda asociada a la cirugía cardiaca bajo circulación extracorpórea
    A.4.1Sponsor's protocol code numberIIBSP-ALB-2017-72
    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 de la Santa Creu i 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 supportInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number34935537636
    B.5.5Fax number34935537812
    B.5.6E-mailuicec@santpau.cat
    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 Albutein 20%
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, 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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN ALBUMIN
    D.3.9.3Other descriptive nameHUMAN ALBUMIN SOLUTION 20%
    D.3.9.4EV Substance CodeSUB176868
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Renal function
    Función renal
    E.1.1.1Medical condition in easily understood language
    Renal function
    Función renal
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    To analyze the effect of the use of human albumin during ECC on the incidence of ARD-ACC in patients undergoing cardiac surgery with CPB diagnosed according to the KDIGO scale during the first 7 days after the intervention.
    Analizar el efecto del empleo de albúmina humana durante la CEC sobre la incidencia de DRA-ACC en los pacientes intervenidos de cirugía cardiaca con CEC diagnosticada de acuerdo a la escala KDIGO durante los 7 primeros días tras la intervención.
    E.2.2Secondary objectives of the trial
    To analyze the perfusion pressures during cardiopulmonary bypass (CPB) in relation to the use of Albumin

    To analyze the balance of fluids administered during surgery.

    To analyze the amount of total bleeding and hemoglobin levels during the postoperative period (hospital stay).

    To analyze the transfusion requirements of blood products during the postoperative period (hospital stay).

    To analyze the requirements of vasoactive and inotropic drugs during the initial postoperative period (72 hours).

    To analyze the body weight of patients during the first 48 hours.

    To analyze plasma levels of albumin during the postoperative period.

    To compare the need for dialysis, the appearance of complications and the length of hospital stay in both groups.

    To analyze the mortality per month of patients undergoing cardiac surgery using CPB.
    Analizar las presiones de perfusión durante la CEC en relación con el uso de Albúmina

    Analizar el balance de fluidos administrados durante la cirugía.

    Analizar la cantidad de sangrado total y los niveles de hemoglobina durante el postoperatorio (estancia hospitalaria).

    Analizar las necesidades de trasfusión de hemoderivados durante el periodo postoperatorio (estancia hospitalaria).

    Analizar los requerimientos de fármacos vasoactivos e inotrópicos durante el postoperatorio inicial (72 horas).

    Analizar el peso corporal de los pacientes durante las primeras 48 horas.

    Analizar los niveles plasmáticos de albúmina durante el periodo postoperatorio.

    Comparar la necesidad de diálisis, la aparición de complicaciones y el tiempo de estancia hospitalaria en ambos grupos.

    Analizar la mortalidad al mes de los pacientes intervenidos de cirugía cardiaca.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients (> 18 years) scheduled for cardiopulmonary bypass surgery with Glomerular Filtration Rate (GFR) greater than or equal to 60 and left ventricular ejection fraction greater than or equal to 40%
    Pacientes adultos (>18 años) programados para cirugía cardiaca mediante CEC, que presenten TFG mayor o igual a 60 y fracción de eyección del ventrículo izquierdo superior o igual al 40%.
    E.4Principal exclusion criteria
    Patients who do not meet the inclusion criteria and those who have a history of allergic reactions to human albumin, as well as those who have received iodinated contrast during the 7 days prior to surgery and pregnant women, will be excluded from the study.
    Se excluirán del estudio los pacientes que no cumplan los criterios de inclusión y aquellos que presenten antecedentes de reacciones alérgicas a la albúmina humana, así como los que hayan recibido contraste yodado durante los 7 días anteriores a la intervención y las mujeres embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoint of the study will be the incidence of acute renal dysfunction associated with cardiac surgery (DRA-ACC) defined as the percentage of patients who develop DRA-ACC within 7 days after surgery.
    DRA-ACC will be defined according to the KDIGO scale, for which the levels of plasma creatinine (mmol / L) will be determined.
    La variable principal del estudio será la incidencia de disfunción renal aguda asociada a cirugía cardiaca (DRA-ACC) definida como el porcentaje de pacientes que desarrollen DRA-ACC durante los 7 días posteriores a la cirugía.
    La DRA-ACC será definida según la escala KDIGO, para lo cual se determinarán los niveles de creatinina plasmática (mmol/L) .
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    7 días
    E.5.2Secondary end point(s)
    -Volume of total bleeding and hemoglobin levels during the postoperative period (hospital stay) in relation to the use of Albumin during CPB.
    -Needs of transfusion of blood products during the postoperative period (hospital stay) in relation to the use of Albumin during CPB.
    - Requirements for vasoactive and inotropic drugs during the initial postoperative period (72 hours) in relation to the use of Albumin during CPB.
    - Body weight of the patients during the first 48 hours in relation to the use of Albumin during CPB
    - Plasma levels of albumin during the postoperative period (hospital stay) in relation to the use of Albumin during CPB
    -Need of dialysis, incidence of postoperative complications, hospital stay.
    -Mortality per month of patients undergoing cardiac surgery by CPB in relation to the use of Albumin during CPB.
    -Volumen de sangrado total y los niveles de hemoglobina durante el postoperatorio (estancia hospitalaria) en relación con el uso de Albúmina durante la CEC.
    -Necesidades de trasfusión de hemoderivados durante el periodo postoperatorio (estancia hospitalaria) en relación con el uso de Albúmina durante la CEC.
    -Requerimientos de fármacos vasoactivos e inotrópicos durante el postoperatorio inicial (72 horas) en relación con el uso de Albúmina durante la CEC.
    -Peso corporal de los pacientes durante las primeras 48 horas en relación con el uso de Albúmina durante la CEC
    -Niveles plasmáticos de albúmina durante el periodo postoperatorio (estancia hospitalaria) en relación con el uso de Albúmina durante la CEC
    -Necesidad de diálisis, incidencia de complicaciones postoperatorias, estancia hospitalaria.
    -Mortalidad al mes de los pacientes intervenidos de cirugía cardiaca mediante CEC en relación con el uso de Albúmina durante la CEC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours, 72 hours and 1 month
    48 horas, 72 horas y 1 mes
    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 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 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
    Última visita del último sujeto
    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 months20
    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: 250
    F.1.3Elderly (>=65 years) No
    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 state250
    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 Decision2017-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-20
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