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    Summary
    EudraCT Number:2017-003115-20
    Sponsor's Protocol Code Number:848041001
    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:2017-10-04
    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 number2017-003115-20
    A.3Full title of the trial
    Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: a prospective randomised multicenter double-blind placebo-controlled clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of haloperidol for the treatment of acute confusional state (delirium) in patients treated at the intensive care
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts:EuRIDICE
    A.4.1Sponsor's protocol code number848041001
    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 SponsorErasmus Medical Center Rotterdam
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center Rotterdam
    B.5.2Functional name of contact pointMathieu van der Jagt
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31107030478
    B.5.5Fax number+31107036978
    B.5.6E-mailm.vanderjagt@erasmusmc.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 Haloperidol
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg
    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.3.4Pharmaceutical 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 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
    Delirium
    E.1.1.1Medical condition in easily understood language
    Acute confusion
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012224
    E.1.2Term Delirium toxic
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10000702
    E.1.2Term Acute delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042275
    E.1.2Term Subacute delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012220
    E.1.2Term Delirium due to a general medical condition
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012226
    E.1.2Term Delirium, cause unknown
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10071313
    E.1.2Term Hypoactive delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10071314
    E.1.2Term Hyperactive delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10071315
    E.1.2Term Mixed delirium
    E.1.2System Organ Class 100000004873
    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 efficacy of haloperidol to resolve delirium in adult critically ill patients and thereby render the patient awake and non-delirious.
    E.2.2Secondary objectives of the trial
    To study the efficacy of haloperidol to reduce ICU-delirium associated short- and long-term burdens (up to one-year), consisting of: 1) mortality; 2) cognitive and functional impairment; 3) patient- and family experiences and psychological sequelae during and after ICU stay; 4) safety concerns associated with haloperidol use.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for eligibility:
    1. Age ≥ 18 years
    2. Admitted to one of six participating ICUs of the EuRIDICE trial.

    Inclusion criteria for randomisation:
    1. Delirium, as assessed with the Intensive Care Delirium Screening Checklist – ICDSC: ≥4 or Confusion Assessment Method for the ICU – CAM-ICU: positive). NB Delirium can occur in the course of ICU admission or be present at admission.
    2. Written Informed Consent is obtained from patient or legal representative
    3. Complies with inclusion criteria but NOT exclusion criteria for eligibility
    E.4Principal exclusion criteria
    Exclusion criteria for eligibility
    1. Admitted to ICU with a neurological diagnosis (such as acute stroke, traumatic brain injury, intracranial malignancy, anoxic coma). Previous non-acute stroke or other previous neurological condition without cognitive deterioration is not an exclusion criterion.
    2. Pregnancy (to be excluded by pregnancy test in women of child baring age)
    3. History of ventricular arrhythmia including “torsade de pointes” (TdP)
    4. Known allergy to haloperidol
    5. History of dementia or an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score ≥ 4
    6. History of malignant neuroleptic syndrome or parkinsonism (either Parkinson’s disease or another hypokinetic rigid syndrome)
    7. Schizophrenia
    8. Inability to conduct valid delirium screening assessment (e.g. coma, deaf, blind) or inability to speak Dutch
    9. The patient is expected to die within 24 hours, or is expected to leave the ICU within 24 hours after evaluation (may be reassessed daily)

    Exclusion criteria for randomisation:
    1. Prolonged QT-interval (QTc > 500ms)
    2. (recent) “torsade de pointes” (TdP)
    3. (recent) malignant neuroleptic syndrome or parkinsonism
    4. Evidence of acute alcohol (or substance) withdrawal requiring pharmacological intervention (e.g. benzodiazepines or alfa-2 agonist) to treat
    5. IQCODE not assessed
    6. The patient is expected to die within 24 hours.
    7. No (previously) signed informed consent by patient or representative
    8. Current participation in another intervention trial that is evaluating a medication, device or behavioural intervention
    E.5 End points
    E.5.1Primary end point(s)
    Delirium- and coma free days at ICU
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 14 days after randomisation
    E.5.2Secondary end point(s)
    • Time from randomisation to resolution of delirium into a wakeful, non-delirious state.
    • Cognitive outcomes in ICU survivors at 3 and 12 months after ICU admission (assessment by trained research nurses or MSc students neuropsychology is feasible) with a brief cognitive assessment battery of validated and repeatable measures of general cognition, memory, language, processing speed, attention and executive functioning and mood (Montreal Cognitive Assessment [MOCA], Rey Auditory Verbal Learning Test, Semantic fluency, Digit Span [WAIS-IV], Trailmaking tests A and B, Boston naming Test [short version], Hospital Anxiety and Depression Scale [HADS]).
    • Functional outcomes and quality of life in survivors at 3 and 12 months after admission (Short Form-36 [SF-36]).
    • Mortality rate at 28 days and one year after randomisation.
    • Time to “readiness for discharge from the ICU”, as is being recorded routinely by all participating hospitals by the treating physicians on a daily basis, as an alternative to length-of-ICU stay which may be determined by other factors (e.g. capacity at the ward) than clinical condition.
    • Adverse drug associated events (prolonged QTc by EKG, muscle rigidity and other associated movements disorders [Simpson Angus Scale] and ventricular arrhythmia’s including torsade de pointes).
    • Patient and family-member well-being and experiences associated with delirium during and after ICU stay, assessed after hospital discharge and at 3 months after randomisation. We have chosen the most appropriate tool after consultation of our patient perspective representatives and the Steering Committee associated with this trial. The tools for this category of secondary outcomes are added to Appendix 2 (including a Table with overview of timing of assessments), and include the ICU Memory Tool (ICU-MT [21]), Delirium Experience Questionnaire (DEQ [22]), Caregiver Strain Index (CSI [23]).
    • Posttraumatic stress syndrome (PTSS) in participants and family-members at 3 months after admission with the Impact of Event Scale – Revisited (IES-R).
    • Maximum ICU Mobility Scale (IMS [24]) during ICU stay (and day of max IMS).
    • Quality of sleep (Richards-Campbell Sleep Questionnaire [RCSQ] [25])
    • Workload experienced by ICU nurses while caring for delirious patients (based on Delirium Experience Questionnaire (DEQ [22]).
    E.5.2.1Timepoint(s) of evaluation of this end point
    During ICU admission, at discharge from hospital, after 28 days, 1 month, 3 months, 6 months and 12 months.
    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 No
    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 concerned6
    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
    LVLS
    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 months6
    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: 349
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 393
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects incapable of giving consent for physical or physiological reasons, or reasons linked to their medical condition (e.g. coma or delirium).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state742
    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)
    During our follow-up phase we will assist patients on reflecting on their intensive care period. This will be done by questionnaires but also by allowing them the possibility to reflect on this period during follow-up visits. Follow-up care will be initiated if after neurocognitive tests we discover cognitive problems or symptoms of anxiety or depression, requiring further treatment. In these cases patients will be referred to their general practitioner.
    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 Dutch ICU-delirium consortium
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-19
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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