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    Summary
    EudraCT Number:2021-005358-28
    Sponsor's Protocol Code Number:ANDROMEDA-SHOCK-2
    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:2022-02-10
    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 number2021-005358-28
    A.3Full title of the trial
    Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)
    Reanimación del Shock Séptico precoz basada en Fenotipos Hemodinámicos y guiada por Tiempo de Rellene Capilar (ANDROMEDA-SHOCK-2): Un Ensayo clínico, aleatorizado, abierto, y multicéntrico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)
    Reanimación del Shock Séptico precoz basada en Fenotipos Hemodinámicos y guiada por Tiempo de Rellene Capilar (ANDROMEDA-SHOCK-2): Un Ensayo clínico, aleatorizado, abierto, y multicéntrico
    A.3.2Name or abbreviated title of the trial where available
    ANDROMEDA-SHOCK-2
    ANDROMEDA-SHOCK-2
    A.4.1Sponsor's protocol code numberANDROMEDA-SHOCK-2
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05057611
    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 SponsorPontificia Universidad Católica de Chile
    B.1.3.4CountryChile
    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 supportPontificia Universidad Católica de Chile
    B.4.2CountryChile
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Apoyo a la Investigación Clínica
    B.5.2Functional name of contact pointPaula Remirez
    B.5.3 Address:
    B.5.3.1Street Addressc/Diego de León, 62
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number+349152025401752
    B.5.6E-mailpaula.remirez@scren.es
    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 Lactato Ringer
    D.2.1.1.2Name of the Marketing Authorisation holderLactato Ringer
    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 nameLactato Ringer
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.IMP: 2
    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 Suero fisiologico para pefusion intravenosa
    D.2.1.1.2Name of the Marketing Authorisation holderSuero fisiologico para pefusion intravenosa
    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 nameSuero fisiológico para perfusión intravenosa
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    Septic shock
    Shock séptico
    E.1.1.1Medical condition in easily understood language
    Septic shock
    Shock séptico
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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 test if a CRT-targeted resuscitation based on clinical hemodynamic phenotyping can improve a hierarchical clinical outcome - mortality, time to cessation of vital support, and length of hospital stay, all within 28 days - in septic shock patients as compared to usual care.
    Probar si una reanimación guiada por el TRC y basada en la fenotipificación hemodinámica puede mejorar un outcome clínico jerarquizado– mortalidad, tiempo hasta el cese del soporte vital, duración de estadía hospitalaria, todo en 28 días - en pacientes con shock séptico en comparación con estándar de cuidado.
    E.2.2Secondary objectives of the trial
    - Overall mortality in 28 days
    - Days free of life support in 28 days
    - Length of hospital stay
    - Mortalidad global en 28 días
    - Días libres de soporte vital en 28 días
    - Duración de la estancia hospitalaria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Consecutive adult patients (≥ 18 years) with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h.
    - Pacientes adultos (≥ 18 años) con shock séptico, definido según el consenso Sepsis-3. Brevemente, el shock séptico se define como una infección sospechada o confirmado, más la presencia de hiperlactatemia y requerimiento de NE por hipotensión persistente luego de la volemización con al menos 1000mL de fluidos en 1h.
    E.4Principal exclusion criteria
    - More than 4 hours since septic shock diagnosis
    - Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period
    - Active bleeding
    - Do not resuscitate status
    - Child B-C Cirrhosis
    - Underlying disease process with a life expectancy < 90 days and/or the attending clinician deems aggressive resuscitation unsuitable
    - Refractory shock (high risk of death within 24h)
    - Pregnancy
    - Concomitant severe acute respiratory distress syndrome.
    - Patients in whom CRT cannot be accurately assessed
    - Más de 4 horas desde el diagnóstico de shock
    - Cirugía o procedimiento de hemodiálisis aguda prevista para comenzar durante el periodo de intervención de 6 horas
    - Sangrado activo
    - Orden de no reanimar
    - Cirrosis Child B-C
    - Enfermedad de base con expectativa de vida <90 días y/o tratante considera que reanimación agresiva es desproporcionada
    - Shock refractario (alta mortalidad en 24h)
    - Embarazo
    - Síndrome de distress respiratorio agudo severo concomitante
    - Pacientes en los que no se puede evaluar con precisión el TRC
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is a hierarchical composite of all cause mortality within 28 days, time to cessation of vital support (truncated at 28 days) and length of hospital stay (truncated at 28 days).

    Time to cessation of vital support, truncated at day 28, is defined as the number of calendar days between randomization and complete absence of requirement of cardiovascular, respiratory and renal support. Resolution of cardiovascular failure implies complete stopping of vasopressor support for at least 24 consecutive hours. Resolution of respiratory failure implies liberation from invasive mechanical ventilation for at least 48 hours. Resolution of renal failure implies liberation of renal replacement therapy for at least 72 hours in those receiving continuous replacement modalities and at least 5 days for those receiving intermittent ones.
    El outcome primario es el compuesto jerarquizado de mortalidad por cualquier causa en 28 días, tiempo hasta la discontinuación del soporte vital (truncado al día 28) y duración de la estadía hospitalaria (truncada al día 28). El tiempo hasta la suspensión del soporte vital, truncado al día 28, se define como el número de días calendario entre la aleatorización y la ausencia total de requerimientos de soporte cardiovascular, respiratorio y renal. La resolución de la insuficiencia cardiovascular implica la interrupción completa del soporte con vasopresores durante al menos 24 horas consecutivas. La resolución de la insuficiencia respiratoria implica la desconexión de la ventilación mecánica invasiva durante al menos 48 horas. La resolución de la insuficiencia renal implica la discontinuación de la terapia de reemplazo renal durante al menos 72 horas en quienes reciban modalidades de reemplazo continuo y al menos 5 días en quienes reciben modalidades intermitentes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.5.2Secondary end point(s)
    - All-cause mortality
    - Vital support free days
    - Length of hospital stay
    - Mortalidad global
    - Días libres de soporte vital
    - Duración de la estadía hospitalaria
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days
    90 días
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Grupo de atención habitual
    Usual Care Group
    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 concerned34
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-02-10. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Considering that the study population is hospitalised in an ICU, written informed consent will be obtained from a legal representative. The patient must confirm or decline participation as soon as his/her clinical situation permits.
    Considerando que la población del estudio esta hospitalizada en una UCI, se obtendrá el consentimiento informado de un representante legal. El paciente debe confirmar o rechazar su participación tan pronto como lo permita su situación clínica.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    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 Decision2022-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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