Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: a prospective randomised multicenter double-blind placebo-controlled clinical trial - Haloperidol for delirium in critically ill patients

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 742 人开始时间: 待定最近更新: 2024年6月11日

试验速览

阶段: 3 期
状态: 招募中
发起方: Erasmus MC, Universitair Medisch Centrum Rotterdam
入组人数: 742

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•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 (See above and exclusion criteria)

排除标准

•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 in patients >= 50 years old or with possible cognitive deterioration
•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

研究者

发起方

Erasmus MC, Universitair Medisch Centrum Rotterdam

相似试验

进行中（未招募）

1 期

EUCTR2017-003115-20-NLErasmus Medical Center Rotterdam742

已完成

不适用

Randomised trial of haloperidol for delirium in critically ill patients

NL-OMON26510Erasmus Medical Center, Rotterdam, The Netherlands742

招募中

3 期

Efficacy of haloperidol on symptom of opium withdrawal.

IRCT201702131457N12Mazandaran University of Medical Sciences74

已完成

3 期

Comparative study of the effect of haloperidol and dexmedetomidine on Restlessness in mechanically ventilated patients following concussion admitted to the intensive care unit of Imam Khomeini Hospital

IRCT20200803048288N1Ahvaz University of Medical Sciences60

尚未招募

不适用

Haloperidol midazolam versus ketamine midazolam in agitated patientsagitation.agitation

IRCT20120130008872N13Tehran University of Medical Sciences70