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    Summary
    EudraCT Number:2015-000057-20
    Sponsor's Protocol Code Number:HC-G-H-1209
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-08-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-000057-20
    A.3Full title of the trial
    PROSPECTIVE, RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTI-CENTRIC, INTERNATIONAL, STUDY ON THE EFFICACY AND SAFETY OF AN EARLY TARGET CONTROLLED PLASMA VOLUME REPLACEMENT THERAPY WITH A BALANCED GELATIN SOLUTION VS A BALANCED ELECTROLYTE SOLUTION IN PATIENTS WITH SEVERE SEPSIS / SEPTIC SHOCK
    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 therapeutic effect and safety of an early controlled plasma volume replacement treatment with a balanced gelatin solution tested against a balanced salt solution in patients with severe septis / septic shock
    A.3.2Name or abbreviated title of the trial where available
    GENIUS (GELATIN IN ICU AND SEPSIS)
    A.4.1Sponsor's protocol code numberHC-G-H-1209
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccovion GmbH
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressHelfmann-Park 10
    B.5.3.2Town/ cityEschborn
    B.5.3.3Post code65760
    B.5.3.4CountryGermany
    B.5.4Telephone number+49619677090
    B.5.5Fax number+4961967709117
    B.5.6E-mailtduerrbaum@clinipace.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 Gelafundin ISO 40 mg/ml Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGelaspan
    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.3.9.1CAS number 8000049276
    D.3.9.3Other descriptive nameSUCCINYLATED GELATIN
    D.3.9.4EV Substance CodeSUB22228
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 number5.55
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 6131904
    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 number3.27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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.3.9.1CAS number 19935-04-8
    D.3.9.3Other descriptive nameCALCIUM CHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 0
    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 number0.20
    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 Yes
    D.3.11.13.1Other medicinal product typeIsotonic colloidal volume substitute
    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 Sterofundin ISO Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSterofundin ISO
    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.3.9.1CAS 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 number6.80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 6131904
    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 number3.27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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.3.9.1CAS number 10035-04-8
    D.3.9.3Other descriptive nameCALCIUM CHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.37
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 0
    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 number0.20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 6915-15-7
    D.3.9.3Other descriptive nameMALIC ACID
    D.3.9.4EV Substance CodeSUB14455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.67
    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 in Severe Sepsis / Septic Shock
    E.1.1.1Medical condition in easily understood language
    Volume replacement in Severe Sepsis / Septic Shock
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 efficacy of early goal directed fluid management of a combination of a gelatin and crystalloid regime in comparison to a pure crystalloid regime in achieving haemodynamic stability (HDS) in patients with severe sepsis / septic shock.
    E.2.2Secondary objectives of the trial
    Investigation of safety and efficacy parameters of the applied fluid regimes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients ≥ 18 years of age
    • Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
    • Patients with body weight ≤ 140 kg
    • Patients diagnosed severe sepsis / septic shock (refer to section 7.2.1 for definitions) at admission on ICU who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during ICU stay who can be enrolled within 90 min after diagnosis
    • Patients where antibiotic therapy has already been started (prior to randomization)
    • Patients who are fluid responsive. Fluid responsiveness is defined as increase of > 10% in mean arterial pressure (MAP) after PLR or fluid challenge (max. 250 ml crystalloid solution)
    • Signed informed consent by patient, legal representative or authorized person or deferred consent
    E.4Principal exclusion criteria
    • Administration of HES, dextrane solutions or > 500 ml Gelatin solution within the 24 h prior to randomization
    • Death expected within the next 48 h (moribund patients as defined by ASA ≥ class V)
    • Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
    • Patients for whom the need of pressure infusions are expected
    • Requirement for renal support (either continuous or discontinuous techniques, including intermittent haemodialysis, haemofiltration and haemodiafiltration)
    • Patients receiving therapeutic heparin medication due to chronic coagulation disease / anticoagulation medication (i.e.partial thromboplastin time > 60 sec)
    • Acutely burned patients:
    Burns are defined as having any of the following before the administration of investigational products:
    1. Burns > 10 % of body surface area classified as third or second-degree yet re-epithelialised
    • Renal failure with oliguria or anuria
    • Severe general oedema
    • Severe congestive cardiac failure
    • Hypersensitivity to the active substance or ingredients of the IPs
    • Hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) or known allergy to red meat (mammal meat) and offal
    • Hypervolaemia / hyperhydration
    • Hyperkalaemia
    • Hypercalcaemia
    • Metabolic alkalosis
    • Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
    E.5 End points
    E.5.1Primary end point(s)
    Time until first / initial HDS is achieved (in minutes).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time measurement will start with first administration of IPs and will be continued until first HDS is achieved.
    E.5.2Secondary end point(s)
    • Safety
    -Renal function
    Serum creatinine (SCr)
    Serum blood urea nitrogen (BUN)
    Estimated glomerular filtration rate (eGFR)
    Need and indication of renal replacement therapy (RRT)
    Urine output
    Kidney Disease Improving Global Outcome (KDIGO) score
    -Coagulation
    Prothrombin time (PT)
    Activated partial thromboplastin time (aPTT)
    International norm ratio (INR)
    -Hepatic function
    Bilirubin
    Adverse Events
    (Serious) adverse events ((S)AEs) / reactions ((S)ARs)
    -Other
    Number of red blood cell (RBC) units
    Number of fresh frozen plasma (FFP) units
    Number of other blood products
    Vasopressor therapy
    Inotropic therapy
    - Efficacy
    Fluid administration according to the volume algorithm
    Volume needed to achieve first / initial HDS
    Total volume until 48 h after randomization
    Administered bottles
    Additional administered crystalloid solutions for further volume treatment
    Drug and volume
    Fluid balance
    Fluid intake
    Fluid output
    Fluid balance
    Haemodynamics
    Volume responsiveness upon passive leg raising (PLR) or exogenous fluid challenge
    Haemodynamic readings as required by the volume algorithm and haemodynamics from 48 h after randomization until ICU discharge or day 28, whatever occurs first
    -Tissue oxygenation and acid base balance
    Arterial blood gas analyses (BGA)
    Serum electrolytes
    Base excess (BE)
    Lactate / lactate decrease
    Central venous BGA
    Arterial oxygen content
    Oxygen delivery

    • Outcome
    Length of stay (LOS) in the intensive care unit (ICU)
    Hospital LOS
    Days on RRT
    Number of infection free days
    Number of antibiotic free days
    Number of ventilator free days
    Number of vasopressor free days
    -Follow-up
    Last available SCr (day 28)
    Colloid therapy (day 28)
    Mortality & cause of death (if applicable) (day 28 & day 90)
    Health-related quality of life (HRQoL) (day 90)
    New RRT / kidney disease (day 90)
    -Other variables
    Demographic data
    Age
    Gender
    Height
    Weight
    Race
    Type of patient (e.g. trauma patient, surgical patient)
    Anamnesis
    APACHE II & SOFA score
    Temperature
    Fluid input in the 24 h prior to randomization
    Origin of sepsis
    Procalcitonin (optional)
    Causative organism of infection
    Medical history
    Concomitant medication
    Antibiotic therapy
    Nephrotoxic therapy
    Contrast agents
    Anticoagulation therapy
    Study termination
    Fibrinogen
    Antithrombin
    Platelets

    Time points of evaluation:
    At random.: Demographics, Anamnesis, Med. history; APACHE II,; At random. until day 7 (once daily): eGFR, KDIGO; From random. to 48 hrs after random. (cont.): Fluid admin. acc. algorithm, Vol. needed to achieve first / initial HDS, Total volume, Vol. responsiveness upon PLR /exog. fluid challenge, Haemodyn. ; At ICU/hospital discharge: LOS; At random. to ICU discharge/day 28 (once daily): Renal function, Coagulation, Hepatic funct. & SOFA score, Temp.; From random.to ICU discharge/day 28 (once daily): RRT need, Urine output, Days on RRT, Con. Med.; From random. to ICU discharge/day 28 (cont.): (S)AEs / (S)ARs, Number of blood product units, Vasopressor/inotropic therapy, Add. admin. cryst. solutions, Fluid balance; From random. until ICU discharge/day 28: within the first 6 hrs every 2 hrs, then every 12 hrs; from 48 hrs until ICU discharge/day 28 (once daily): Tissue oxygenat. /acid base balance, S. electrolytes; Cumul.: infection/antibiotic/ventilator/vasopressor free days; Day 28: Last available SCr, Colloid therapy, Day 28 + 90: Mortality & cause of death (if applic.), Day 90: HRQoL, New RRT/kidney disease
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Completion of last follow up of last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 304
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 304
    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 2015-08-10. 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
    Study indication is severe sepsis or septic shock, therefore patients are in an emergency situation. In the setting of emergency situation, requiring ICU admission / immediate medical treatment, the patients will not be able to consent personally.
    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 608
    F.4.2.2In the whole clinical trial 608
    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 that condition. Treatment after study end is left to Medical standard of Care.
    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 Decision2015-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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