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    Summary
    EudraCT Number:2017-003362-27
    Sponsor's Protocol Code Number:WO17.123
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003362-27
    A.3Full title of the trial
    Ketanserin effects on Peripheral Temperature and Lactate
    De effecten van Ketanserine op de perifere temperatuur en lactaat
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of the medicine Ketanserin on Peripheral Temperature and Lactate
    De effecten van het medicijn Ketanserine op de perifere temperatuur en lactaat
    A.3.2Name or abbreviated title of the trial where available
    KoPTaL
    KoPTaL
    A.4.1Sponsor's protocol code numberWO17.123
    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 SponsorOLVG
    B.1.3.4CountryNetherlands
    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 supportOLVG
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOLVG
    B.5.2Functional name of contact pointIntensive Care Unit
    B.5.3 Address:
    B.5.3.1Street AddressOosterpark 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1091 AC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number`00310205993007
    B.5.6E-mailp.h.j.vandervoort@olvg.nl
    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 Ketanserin
    D.2.1.1.2Name of the Marketing Authorisation holderProstrakan
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameKetanserin
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    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
    Critical illness
    Delta temperature greater than 6.0 °C
    Kritieke ziekte
    Delta temperatuur groter dan 6.0 °C.
    E.1.1.1Medical condition in easily understood language
    Critical illness/ ICU patient
    Delta temperature greater than 6.0 °C/ Decreased blood circulation
    Kritieke ziekte/ IC patient
    Delta temperatuur groter dan 6.0 °C./ Slechte bloedcirculatie
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    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 determine the effects of a continuous ketanserin infusion on peripheral temperature and lactate clearance in critically ill patients with either a high lactate or a high deltaTemperature.
    Het onderzoeken van de effecten van continue intraveneuze toediening van Ketanserine op perifere temperatuur en klaring van het lactaat bij patiënten met een hoge deltaTemperatuur.
    E.2.2Secondary objectives of the trial
    Change in lactate (measured per 2 hours)
    Verandering in lactaat (per twee uur gemeten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - DeltaTemperature greater than 6.0 °C.
    - Age 18 years or older
    - Admitted to the ICU for any reason
    - Written informed consent from the patient or legal representative
    - Delta temperatuur groter dan 6 graden celcius
    - 18 jaar of ouder
    - opgenomen op de ICU voor elke reden
    - geschreven informed consent
    E.4Principal exclusion criteria
    - Pregnancy
    - No possibility to obtain informed consent
    - QTc above 550 msec,
    - Arrhythmias, including bradycardia defined as a heart rate below 50/min; 2nd and 3rd degree AV block; ventricular tachycardia
    - Blood Potassium level < 3.5 mmol/l
    - Blood Magnesium level <0.5 mmol/l
    - Allergy for ketanserin
    - DeltaTemperature less than 6°C.
    - Patients undergoing therapeutic hypothermia
    - Patients admitted after cardiac arrest
    - Patients admitted after cardiac surgery
    3.3 Exclusie criteria
    - Zwangerschap
    - Geen mogelijkheid tot het verkrijgen van informed consent
    - QTc langer dan 550 milliseconden
    - Aritmieen , inclusief bradycardie gedefinieerd als een hart frequentie lager dan 50/min; 2de and 3de graads AV blok; ventriculaire tachycardie
    - Kalium (bloed) < 3.5 mmol/l
    - Magnesium (bloed) <0.5 mmol/l
    - Allergie for ketanserine
    - DeltaTemperatuur minder dan 6°C.
    - Patiënten die behandeld worden met therapeutische hypothermie
    - patienten opgenomen na reanimatie
    - patienten opgenomen na hartchirurgie
    E.5 End points
    E.5.1Primary end point(s)
    Change in DeltaTemperature (measured per hour)
    Verandering in Delta Temperatuur (per uur gemeten)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Temperature measurements
    Time=0 hour (start infusion IMP or placebo)
    T= 1 hour (after start infusion), T= 2 hour, T= 3 hour, T=4 hour, T= 5 hour, T= 6 hour, T= 7 hour, T= 8 hour (stop infusion IMP or placebo)
    Temperatuur metingen
    Tijd=0 uur (start infusie IMP of placebo)
    T= 1 uur (na start infusie), T= 2 uur, T= 3 uur, T= 4 uur, T= 5 uur, T= 6 uur, T= 7 uur, T= 8 uur (stop infusie IMP of placebo)
    E.5.2Secondary end point(s)
    -Change in lactate (measured per 2 hour)

    -To determine ketanserin serum levels in retrospect.
    Verandering in lactate ( per 2 uur gemeten)


    Bepalen van de ketanserine serum levels ( achteraf)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - To calculate lactate clearance every two hours a 2 ml arterial blood sample for lactate measurement will be collected and sent for immediate analysis : T=0 hour (start infusion IMP or placebo) , T= 2 hour, T=4 hour, T= 6 hour, T= 8 hour (stop infusion IMP or placebo)

    - At T=4 hr and T=8 hr a 6 ml blood sample will be drawn to determine ketanserin serum levels in retrospect.
    Verandering in lactate ( per 2 uur gemeten)
    T=0 (start infusie IMP of placebo) , T= 2 uur, T= 4 uur, T= 6 uur, T= 8 uur (stop infusie IMP of placebo)

    Op T=4 uur en T=8 uur wordt 6 ml bloed afgenomen om de ketanserine serum levels achteraf te bepalen.
    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 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 concerned3
    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
    The end of the trial is at T=8 hours (= stop infusion study medication (IMP or placebo) after start of the IMP or placebo. There will be no measurements after T=8 hour
    Het einde van het onderzoek is op T= 8 (stop infuus studiemedicatie) uur na na start van het IMP of de placebo. Na T=8 uur zijn er geen metingen meer.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    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
    Critically ill patients are, due to their illness and level of conciousness, often not capabel to give informed consent
    Door de aard van de ziekte zijn IC-patiënten vaak/meestal niet in staat om informed consent te geven
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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
    Geen
    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 Decision2017-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-02
    P. End of Trial
    P.End of Trial StatusOngoing
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