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    Summary
    EudraCT Number:2008-007237-47
    Sponsor's Protocol Code Number:PHYDELIO
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-11-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-007237-47
    A.3Full title of the trial
    Perioperative physostigmine prophylaxis for liver resection patients at risk for delirium and postoperative cognitive dysfunction

    Perioperative Gabe von Physostigmin bei Leberteilresktion zur Prophylaxe von Delir und postoperativem kognitivem Defizit
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Perioperative physostigmine prophylaxis for liver resection patients at postoperative risk for confusion, lack of concentration and orientation and postoperative cognitive dysfunction.
    A.3.2Name or abbreviated title of the trial where available
    PHYDELIO
    A.4.1Sponsor's protocol code numberPHYDELIO
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN18978802
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportCharité - Universitätsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointUniv. - Prof. Dr. Claudia Spies
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1, Campus Virchow Klinikum
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930551102
    B.5.5Fax number+4930551909
    B.5.6E-mailclaudia.spies@charite.de
    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 Anticholium
    D.2.1.1.2Name of the Marketing Authorisation holderDr. F. Köhler Chemie
    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 nameAnticholium
    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 INNPhysostigmine Salicylate
    D.3.9.1CAS number 57-64-7
    D.3.9.2Current sponsor codeAnticholium
    D.3.9.3Other descriptive namePHYSOSTIGMINE SALICYLATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The drug physostigmine will be investigated in patients (men and women)undergoing a liver resection. The study medication will be administered by intravenous infusion continuously (24 hours) to prevent/reduce the rate of Delirium and the incidence of the postoperative cognitive dysfunction.
    E.1.1.1Medical condition in easily understood language
    Postoperative risk for confusion, lack of concentration and orientation and postoperative cognitive dysfunction.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    Mutiple objective

    Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)

    Cambridge Neurophysiological Test Automated Battery (CANTAB)
    E.2.2Secondary objectives of the trial
    - Diagnostics, Frequency, Duration, Delirium-free days of Delirium
    - Diagnostics, Frequency, Duration, Delirium-free days of subsyndromal Delirium
    - Evaluation of intensive care unit performance
    - Length of postoperative hospital stay
    - Length of postoperative intensive care unit stay
    - Pain
    - The rate of postoperative organ dysfunctions and complications
    - Incidence of systemic inflammatory response syndrome (SIRS) and infection
    - Immune parameters
    - Quality of life (questionnaires)
    - Mortality
    - Innovative Parameter of renal function
    - Parameter of hematology (Sysmex)
    - Cortisol level
    - Venous return
    - Calcification propensity
    - Heart rate variability
    - Transthoracic echocardiography
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    male or female patients
    age ≥ 18
    planned elective liver resection with or without additional elective surgery in the same session
    able to give written informed consent
    offered patient information and informed consent
    no participation in another clinical trial (one month before and during the study period)
    negative pregnancy test (ß-HCG in urine)
    E.4Principal exclusion criteria
    pregancy or lactation
    lacking willingness to save and hand out pseudonymised data within the study
    accomodation in an institution due to an official or judical order
    Charité employee
    illiteracy
    unability of German language use
    visual and acustical impairment
    score on the minimental state examination (MMSE) at screening of 23 or less
    ASA Classification > IV
    wedge resection
    ascertained psychiatric disease
    intake of psychotropic drugs (including sleeping pills and Benzodiazepine)
    AIDS (CDC - classification "C")
    Neoadjuvant chemo - or radiotherapy within the last 28 days
    rheumatoid diseases
    vagotomy
    symptomatic bradycardia
    known prolongation of QTc - interval (> 456 ms)
    regular intake of amiodarone or cholinesters
    vagus nerve stimulation in epilepsy
    asthma bronchiale
    allergies and sensibility to physostigmine salicylate
    allergies to any ingredient of the electrode fixing material (only for participants of sleep stage assessment).
    E.5 End points
    E.5.1Primary end point(s)
    1. Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)

    2. Cambridge Neurophysiological Test Automated Battery (CANTAB)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV), measured pre-operatively and up the the 7th post-operative day
    2. Cambridge Neurophysiological Test Automated Battery (CANTAB), measured pre-operatively, on the 7th, 90th and 365th post-operative day

    The study will end seven years and 11 months after recruitment of the first Patient. The primary endpoint can be evaluated for every patient after mean follow-up 1 year.
    E.5.2Secondary end point(s)
    1a. Delirium (Diagnostic, Frequency, Duration, Delirium-free days):
    Confusion Assessment Method (CAM)/Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) , Intensive Care Delirium Screening Checklist (ICDSC) , Delirium Detection Scale (DDS) , Delirium Rating Scale (DRS) , NuDESC (Nursing Delirium Screening Scale);
    1b Delirium (Frequency, Duration, Delirium-free days): DSM IV
    1c: Subsyndromal Delirium (Diagnostic, Frequency, Duration, Delirium-free days):
    Intensive Care Delirium Screening Checklist (ICDSC) , Delirium Detection Scale (DDS), NuDESC (Nursing Delirium Screening Scale)
    2. Evaluation of intensive care unit performance:
    2.1. Simplifies Acute Physiology Score (SAPS II)
    2.2. Acute Physiological and Chronic Health Evaluation (Apache II)
    2.3. Sequental Organ Failure Assessment (SOFA)
    2.4. Therapeutic Interventions Scoring System (TISS)
    2.5. Richmonds Agitation Sedations Scale (RASS)
    2.6. Glasgow Coma Scale (GCS)
    2.7. Risk Injury Failure Loss End Stage Kidney Disease (RIFLE)
    3. Length of post-operative hospital stay, measured by Post-anaesthesia Discharge Scoring Stay (PADSS)
    4. Length of post-operative intensive care unit stay according to the criteria of internal standard operating procedures (SOP)
    5. Pain:
    5.1. Numeric Rating Scale (NRS)
    5.2. Verbal Rating Scale (VRS)
    5.3. Visual Analogue Scale (VAS)
    5.4. Behavioural Pain Scale (BPS)
    6. The rate of post-operative organ dysfunctions and complications: cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunction
    7. Incidence of systemic inflammatory response syndrome (SIRS) and infection, measured by CDC and American Thoracic Society (ATS) criteria
    8. Laboratory parameters of immunology and hematology (Sysmex)
    9.1 Quality of life (questionnaires): 12-item short form health survey
    (SF-12), EuroQoL instrument (EQ-5D)
    9.2. Barthel Index (ADL/IADL)/Instrumental Activity of Daily Living
    (IATL) (German: Instrumentelle Aktivität im täglichen Leben)
    9.3. Geriatric Depression Scale (GDS), Cornell Depression Scale (CDS),
    Hospital Anxiety and Depression Scale deutsche Version (HADS-D)
    10. Mortality
    11.Innovative Parameter of renal function
    12. Cortisol Level
    13. Venous return
    14. Heart rate variability
    15. Calcification propensity
    16. Transthoracacic echocardiography
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. -8. The secondary outcome parameters will be measured as below not specified pre-operatively and up the the seventh post-operative day. 9.1-9.3 before the operation, at the day of hospital discharge, 3 months and one year after surgery; 10. post-operative survival after 90 days, after 6 months and after one year;11: before the operation until first day after operation 12. at inclusion day, and first day after the operation; 13. perioperatively until the end of operation; 14. and 15; 16. at inclusion day and directly after the operation.
    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 No
    E.6.5Efficacy No
    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) No
    E.8.2.2Placebo Yes
    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
    Last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 213
    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 No
    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 state271
    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)
    information to the general practitioner in charge of the patient after hospital stay
    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 Decision2008-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-10-19
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