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    Summary
    EudraCT Number:2016-002162-30
    Sponsor's Protocol Code Number:HC-G-H-1504
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2017-04-21
    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 number2016-002162-30
    A.3Full title of the trial
    Prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery
    Estudio prospectivo, aleatorizado, doble-ciego, internacional y multicéntrico sobre la seguridad y la eficacia de la solución 6% Hydro-xyethyl starch (HES) comparada con una solución electrolítica en pacientes sometidos a cirugía abdominal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Controlled, international study conducted in several centres on the safety and therapeutic effect of a Hydroxylethyl-starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery
    Estudio para investigar la seguridad y la eficacia de un sustituto de volumen plasmático que contiene hydroxyethyl-stach (HES) en pacientes de cirugía abdominal
    A.3.2Name or abbreviated title of the trial where available
    PHOENICS
    A.4.1Sponsor's protocol code numberHC-G-H-1504
    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 SponsorB. Braun Melsungen AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportB. Braun Melsungen AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFresenius Kabi Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationB. Braun Medical SA
    B.5.2Functional name of contact pointRicard Rosique
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Terassa 121
    B.5.3.2Town/ cityRubi
    B.5.3.3Post code08191
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935902283
    B.5.5Fax number00349359022572290
    B.5.6E-mailricard.rosique@bbraun.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 Volulyte 6% solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoly(O-2-hydroxyethyl)starch
    D.3.9.1CAS number 9005-27-0
    D.3.9.3Other descriptive nameHydroxyethyl starch 130/0.4
    D.3.9.4EV Substance CodeSUB90155
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagensium chloride hexahydrate
    D.3.9.1CAS number 7791-18-6
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium acetate trihydrate
    D.3.9.1CAS number 6131-90-4
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB15266MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    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 IONOLYTE solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi España S.A.U.
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium chloride hexahydrate
    D.3.9.1CAS number 7791-18-6
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium acetate trihydrate
    D.3.9.1CAS number 61341-90-4
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB15266MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    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
    Hypovolaemia due to acute blood loss in elective abdominal surgery
    Tratamiento de hipovolemia
    cirugía abdominal electiva
    E.1.1.1Medical condition in easily understood language
    Decreased blood volume due to acute blood loss during scheduled surgery of the abdomen
    Disminución del volumen sanguíneo (hipovolemia) debida a sangrado intenso durante la cirugía abdominal programada
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10021137
    E.1.2Term Hypovolaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the safety and efficacy of a 6% HES 130 versus an electrolyte solution in patients undergoing elective abdominal surgery
    Investigar la seguridad de una solución 6% HES (Volulyte 6%) frente a una solución electrolítica (Ionolyte) en pacientes sometidos a cirugía abdominal electiva.
    E.2.2Secondary objectives of the trial
    Further investigation of safety and efficacy of the applied products
    Investigación adicional sobre la seguridad y la eficacia de los productos de investigación empleados
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female adult patients > 40 and ≤ 85 years of age
    Women of childbearing potential must test negative on standard pregnancy test (urine or serum)
    Patients undergoing elective abdominal surgery with an expected blood loss of ≥ 500 ml
    ASA Physical Status II-III
    Signed written consent form
    Pacientes adultos de ambos géneros > 40 y ≤ 85 años de edad.
    Las mujeres en edad fértil deben dar un resultado negativo en un test de embarazo estándar (orina o suero)
    Pacientes sometidos a cirugía abdominal electiva con una pérdida esperada de sangre ≥ 500 ml
    Estado ASA II-III
    Consentimiento informado firmado
    E.4Principal exclusion criteria
    Hypersensitivity to the active substances or to any of the other excipients of the investigational products
    Body weight ≥ 140 kg
    Sepsis
    Burns
    Renal impairment (AKIN stage ≥ 1) or acute and/or chronic renal replacement therapy
    Intracranial or cerebral haemorrhage
    Critically ill patients (typically admitted to the intensive care unit)
    Dehydration
    Hyperhydration
    Pulmonary oedema
    Congestive heart failure
    Severe hypernatraemia,
    Severe hyperchloraemia
    Hyperkalaemia
    Metabolic alkalosis
    Severely impaired hepatic function
    Severe coagulopathy
    Organ transplant patients
    Simultaneous participation in another interventional trial (drugs or medical device)
    Hipersensibilidad a la sustancias activas o a cualquier excipiente de los productos médicos en investigación
    Peso corporal ≥ 140 kg
    Sepsis
    Quemaduras
    Trastorno renal (estado AKIN ≥ 1) o terapia de reemplazo renal aguda o crónica
    Hemorragia intracraneal o cerebral
    Pacientes críticos (típicamente admitidos en la unidad de cuidados intensivos)
    Hiperhidratación
    Deshidratación
    Edema pulmonary
    Insuficiencia cardiaca congestiva
    Hipernatremia severa
    Hipercloremia severa
    Hiperpotasemia
    Alcalosis metabólica
    Función hepática gravemente deteriorada
    Coagulopatía severa
    Pacientes con trasplante de órganos
    Participación simultánea en otros ensayos clínicos de intervención (estudios con medicamentos o dispositivos médicos)
    E.5 End points
    E.5.1Primary end point(s)
    Difference in mean estimated glomerular filtration rate (eGFR) between the two treatment groups, calculated from the highest Cystatin-C level measured during post-operative days (POD) 1-3.
    Diferencias en la media de la tasa de filtración glomerular estimada (TFG estimada: TFGe) (calculado desde los niveles más altos de cistatina-C medidos durante los días 1-3 postoperatorios (DOP 1-3)) entre los dos grupos de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cystatin-C levels will be determined on POD 1-3. eGFR will be calculated from the highest Cystain-C level during this period.
    Los niveles de cistatina C se determinarán en los días posoperatorios 1-3. La Tasa de Filtración Glomerular estimada (TFGe) se calculará a partir del nivel más alto de cistatina C durante este período.
    E.5.2Secondary end point(s)
    Safety
    - Renal function: Cystatin-C, serum creatinine (SCr), Cystatin-C based estimated glomerular filtration rate (eGFR), Cystatin-C based mean eGFR, SCr based eGFR, AKIN score, RIFLE score, unrine output (if available)
    - Coagulation: Platelet count, International norm ration (INR), activated partial thromboplastin time (aPTT)
    - Inflammation: C-reactive protein (C-RP)
    - Adverse events: (serious) adverse events ((S)AEs / reactions ((S)ARs)
    - Calculated red blood cell (RBC) loss
    - Estimated intra-operative blood loss

    Outcome: Length of stay (LOS) in the hospital (LOS-H), LOS in the intensive care unit (LOS-ICU; if applicable), fit for discharge from ICU / hospital, hours on mechanical ventilation (MV), mortality (in hospital/out of hospital) and its cause, days on RRT, (new) renal replacement therapy (RRT)

    Efficacy
    - Fluid administration: administration of IP volume
    - Fluid balance: fluid input and output
    - Haemodynamics / vital signs: temperature (T), heart rate (HR), mean arterial pressure (MAP), systolic arterial blood pressure (SAP), diastolic arterial blood pressure (DAP), central venous pressure (CVP, if available)
    - At least one of the following parameters to evaluate responsiveness and guide administration (vol guide): stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), pulse pressure variation (PPV)
    Arterial Blood Gas Analysis (ABGA): partial pressure of carbondioxide (pCO2), partial pressure of oxygen (pO2), hydrogen carbonate (HCO3-), arterial oxygen saturation (SaO2), haemoglobin (Hb), haematocrit (Hct), pH, base excess (BE), lactate
    centralvenous oxygen saturation (ScvO2)
    Serum electrolytes (S elyte): Sodium, potassium, calcium, chloride
    Major post-operative complications

    Definition of time-points
    Screening (within 1 week before surgery)
    T0 (Baseline; after randomization and prior to induction of anaesthesia)
    T1 (during surgery)
    T2 (end of surgery)
    T3 (POD 1 morning)
    T4 (POD 2-3 morning)
    T5 (POD 4-7 morning or hospital discharge, whatever occurs first )
    T6 (POD 8-10 morning or hospital discharge, whatever occurs first)
    T7 ( POD 28) ± 5 days
    T8 (POD 90) ± 14 days
    T9 (1 year PO) ± 30 days
    Seguridad
    -Función renal: Cistatina-C, Creatinina sérica (Crs), Tasa de filtración glomerular estimada (TFGe) basada en cistatina-C, Media de TFG estimada basada en cistatina-C, Crs basado en TFGe, Escalas AKIN y RIFLE, Producción de orina
    -Coagulación: Recuento plaquetario, Relación normalizada internacional (INR), Tiempo activación parcial de la tromboplastina (PTTa)
    - Inflamación: Proteína C-reactiva
    - Eventos adversos: Eventos o reacciones adversos (serios) ((S)EAS/(S)RAS)
    - Pérdida calculada de células rojas sanguíneas (CRS)
    - Pérdida de sangre estimada intra-operatoria

    Resultados: Duración de la estancia hospitalaria (LOS), Duración de la estancia hospitalaria en la unidad de cuidados intensivos (UCI) (si aplica), Razón del alta UCI/hospital, Horas de ventilación mecánica, Mortalidad dentro o fuera del hospital (incluida causa), Terapia de reemplazo renal (TRR)

    Eficacia
    -Administración de fluidos
    -Administración de volumen de producto en investigación
    - Balance de fluidos: Entrada y salida de fluidos
    - Signos vitales/hemodinámicos: Ritmo cardiaco (FC), Temperatura (T), Presión arterial media (PAM), Presión arterial sistólica (PAS), Presión arterial diastólica (PAD), Presión venosa central (PVC) (si está disponible)
    - Al menos uno de los siguiente parámetros para evaluar la respuesta a volumen y orientar la administración del producto en investigación dentro del algoritmo de volume: Volumen sistólico (VS), Variación del volumen sistólico (VVS), Índice de volumen sistólico (IVS), Variación en la presión de pulso (VPP), Presión arterial media (PAM)

    Datos de laboratorio
    -Análisis de gases arteriales (GAB): Presión parcial de dióxido de carbono (pCO2), Presión parcial de oxígeno (pO2), Bicarbonato (HCO3-), Saturación arterial de oxígeno (SaO2), Hemoglobina (Hb), Hematocrito (Hct), pH, Exceso de bases, Lactato
    -Saturación venosa central de oxígeno (si está disponible)
    -Electrolitos en suero: Sodio (Na+), Potasio (K+), Calcio (Ca2+), Cloro (Cl-)
    - Complicaciones postoperatorias mayores (incluyendo renales)

    Calendario de visitas
    Selección (una semana antes de la cirugía)
    T0 Base de referencia (Depués de la aleatorización y antes de la inducción de la anestesia)
    T1 (Durante la cirugía)
    T2 (Final de la cirugía)
    T3 (1ª mañana post-operatorio)
    T4 (2º hasta 3º mañana postoperatoria)
    T5 (4º hasta 7º mañana postoperatoria, o alta hospitalaria, lo que ocurra primero)
    T6 (8º hasta 10º mañana postoperatoria, o alta hospitalaria, lo que ocurra primero)
    T7 (día 28 tras la cirugía, ± 5 días)
    T8 (día 90 tras la cirugía, ± 14 días)
    T9 (1 año tras la cirugía, ± 30 días)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cystatin-C: T0, T2-T8
    SCr: T0, T2, T3, T4, T7, T8
    Cystatin-C-based eGFR: T0, T2, T3, T4, T7, T8
    Cystatin-C-based mean eGFR: T3-T6
    SCr-based eGFR: T0, T2, T3, T4, T7, T8
    AKIN stage: T0, T2, T3, T4, T7, T8
    RIFLE category: T0, T2, T3, T4, T7, T8
    Urin output: T0, T2-T4
    Coagulation: T0, T2, T3
    C-RP: T0, T2, T3
    (S)AEs/(S)ARs: T0-T5
    Blood loss - RBC:T4 & intra-op: T2
    LOS-H, LOS-ICU, Fit for discharge - H & ICU: daily
    MV: T0-T5
    Mortality (+ cause): T2-T5, T7, T8
    RRT: T2-T5
    new RRT after POD 7 or H- discharge: T7, T8
    IP intake, fluid in-/output, fluid bal: T0-T4
    T: T0, T2-T4
    HR, MAP, SAP, DAP, CVP: T0, T1 (at least q 30 min), T2-T4
    vol guide: during IP admin
    ABGA: T0 + T2 (all); T3 + T4 (only Hb, Hct, lactate)
    ScvO2: T0, T2, T3
    S Elyte: T0, T2, T3
    Maj compl: T3-T5, T7, T8
    Cistatina-C: T0, T2-T8
    Crs: T0, T2, T3, T4, T7, T8
    TFGe basada en cistatina-C: T0, T2, T3, T4, T7, T8
    Media de TFG estimada basada en cistatina-C: T3-T6
    Crs basado en TFGe: T0, T2, T3, T4, T7, T8
    Escalas AKIN y RIFLE: T0, T2, T3, T4, T7, T8
    Producción de orina: T0, T2-T4
    Coagulación: T0, T2, T3
    C-RP: T0, T2, T3
    (S)EAs/(S)RAs: T0-T5
    Pérdida sangre- CRS: T4 & Durante la cirugía: T2
    LOS-H, LOS-UCI, Razón del alta UCI/hospital:diario
    VM: T0-T5
    Mortalidad: T2-T5, T7, T8
    TRR: T2-T5
    TRR: T7, T8
    Balance de fluidos: T0-T4
    T: T0, T2-T4
    FC, PAM, PAS, PAD, PVC: T0, T1,T2-T4
    Administración de volumen de producto en investigación: T1-T3
    GAB: T0 + T2 (todas); T3 + T4 (solo Hb, Hct, lactato)
    ScvO2: T0, T2, T3
    Electrolitos: T0, T2, T3
    Compl myores: T3-T5, T7, T8
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Serbia
    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
    POD7 or hospital discharge, whatever occurs first for last patient
    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
    E.8.9.2In all countries concerned by the trial years2
    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: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 780
    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 2017-04-21. 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 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 state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2280
    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)
    Not different from the expected normal treatment of the condition.
    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 Decision2017-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-22
    P. End of Trial
    P.End of Trial StatusRestarted
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