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    Summary
    EudraCT Number:2009-010104-28
    Sponsor's Protocol Code Number:2008-262
    National Competent Authority:Iceland - IMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-15
    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 ConcernedIceland - IMCA
    A.2EudraCT number2009-010104-28
    A.3Full title of the trial
    Effects of hydroxyethyl starch 130/0.4 compared to a balanced crystalloid solution on mortality and kidney
    failure in patients with severe sepsis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Norræn vísindarannsókn á notkun sterkjulausna í alvarlegri sýklasótt eða sýklasóttarlosti – 6S rannsóknin
    A.3.2Name or abbreviated title of the trial where available
    The 6S Trial
    A.4.1Sponsor's protocol code number2008-262
    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 SponsorDept. of Intensive Care, Rigshopitalet
    B.1.3.4CountryDenmark
    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 supportDanish Research Council
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of Intensive Care, Rigshospitalet
    B.5.2Functional name of contact pointDept. of Intensive Care
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post codeDK-2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number45354582333
    B.5.6E-mailanders.perner@rh.regionh.dk
    D. IMP Identification
    D.IMP: 1
    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 Tetraspan 6%
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical A/S
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Implantation
    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 typesynthetically modified starch
    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 Ringerfundin
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical A/S
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 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 Yes
    D.3.11.13.1Other medicinal product typeelectrolyte solution
    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
    Severe sepsis or septic shock
    E.1.1.1Medical condition in easily understood language
    Svæsin sýklasótt eða sýklasóttarlost
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 assess the effects of HES 130/0.4 compared with a balanced crystalloid solution on mortality and endstage kidneyfailure in patients with severe sepsis
    E.2.2Secondary objectives of the trial
    To assess the effects of HES 130/0.4 compared with a balanced crystalloid solution on
    · Sepsis-related organ failure assessment (SOFA, modified from (19), see Appendix 5) score (excluding Glasgow
    Coma Score) at day 5 after randomisation
    ·Kidney failure (SOFA score > 2 in the kidney component) at any time during the ICU stay after randomisation
    ·Development of kidney failure (doubling of p-creatinine values) during the ICU stay after randomisation
    ·Development of acidosis as the lowest recorded pHa during the ICU stay after randomisation
    ·Need of dialysis/haemofiltration
    ·Need of ventilation
    ·Days alive without dialysis/haemofiltration
    ·Days alive without ventilation
    ·Hospital length of stay for survivors
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All adult patients who
    ·Undergo resuscitation in the ICU
    ·AND fulfilment within the previous 24 hours of the criteria for severe sepsis according to the Society of Critical
    Care Medicine/American College of Chest Physicians (SCCM/ACCP), see Appendix 1
    ·AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)
    E.
    E.4Principal exclusion criteria
    ·Age < 18 years
    ·Previously randomised in the 6S trial
    ·Allergy towards hydroxyethyl starch or malic acid
    ·Treatment with > 1000 ml’s of any synthetic colloid within the last 24 hours prior to randomisation
    ·Any form of renal replacement therapy
    ·Acute burn injury > 10% body surface area
    ·Severe hyperkalaemia, p-K > 6.0 mM
    ·Liver or kidney transplantation during current hospital admission
    ·Intracranial bleeding within current hospitalisation
    ·Enrolment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
    ·Withdrawal of active therapy
    E.5 End points
    E.5.1Primary end point(s)
    The composite outcome measure of 90-day mortality or end-stage kidney disease defined as dialysis-dependency
    90 days after randomisation will be the primary outcome measure, and these two outcome measures will also be
    analysed separately
    E.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days
    E.5.2Secondary end point(s)
    • Twenty-eight-day, 6-month and 1-year mortality
    • Sepsis-related organ failure assessment (SOFA, modified from (21), see Appendix 5) score (excluding Glasgow Coma Score) at day 5 after randomisation
    • Kidney failure (SOFA score > 2 in the kidney component) at any time in the ICU after randomisation
    • Development of kidney failure (doubling of p-creatinine values) in the ICU after randomisation
    • Development of acidosis as the lowest recorded pHa in the ICU after randomisation
    • Need of dialysis/haemofiltration
    • Need of ventilation
    • Days alive without dialysis/haemofiltration in 90 days after randomisation
    • Days alive without ventilation in 90 days after randomisation
    • Hospital length of stay for survivors sanctioned at 90 days after randomisation

    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days, 6 months and 1 year
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    The independent Data Monitoring and Safety Committee - DMSC - will recommend pausing or stopping the trial
    if
    ·Group-difference in the primary outcome measure is found at the interim analysis
    ·Group-difference in 30- or 90-day mortality is found at the interim analysis
    ·Group-difference in SUSARs or SARs is found at the interim analysis
    ·Results from other trials show clear benefit or harm with one of the trial fluids
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 2011-09-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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
    Consent will be acquired from next of kin or power of attorney following Icelandic laws and regulations
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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)
    Standard care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Copenhagen Trial UNit
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-14
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