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Effectiveness of haloperidol for the treatment of acute confusional state (delirium) in patients treated at the intensive care

Phase 1
Conditions
Delirium
MedDRA version: 21.0Level: LLTClassification code 10012224Term: Delirium toxicSystem Organ Class: 100000004873
MedDRA version: 21.1Level: LLTClassification code 10000702Term: Acute deliriumSystem Organ Class: 100000004873
MedDRA version: 21.1Level: LLTClassification code 10042275Term: Subacute deliriumSystem Organ Class: 100000004873
MedDRA version: 21.0Level: LLTClassification code 10012220Term: Delirium due to a general medical conditionSystem Organ Class: 100000004873
MedDRA version: 21.0Level: LLTClassification code 10012226Term: Delirium, cause unknownSystem Organ Class: 100000004873
MedDRA version: 21.0Level: LLTClassification code 10071313Term: Hypoactive deliriumSystem Organ Class: 100000004873
MedDRA version: 21.0Level: LLTClassification code 10071314Term: Hyperactive deliriumSystem Organ Class: 100000004873
MedDRA version: 21.0Level: LLTClassification code 10071315Term: Mixed deliriumSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Registration Number
EUCTR2017-003115-20-NL
Lead Sponsor
Erasmus Medical Center Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
742
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 349
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 393

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To assess the efficacy of haloperidol to resolve delirium in adult critically ill patients and thereby render the patient awake and non-delirious.;Secondary Objective: 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.;Primary end point(s): Delirium- and coma free days at ICU ;Timepoint(s) of evaluation of this end point: Up to 14 days after randomisation
Secondary Outcome Measures
NameTimeMethod
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