EUCTR2017-003115-20-NL进行中（未招募）1 期
Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: a prospective randomised multicenter double-blind placebo-controlled clinical trial - Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts:EuRIDICE
Erasmus Medical Center Rotterdam0 个研究点目标入组 742 人开始时间: 2017年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 742
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •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
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
- •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
相似试验
招募中
3 期
Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: a prospective randomised multicenter double-blind placebo-controlled clinical trialNL-OMON48650Erasmus MC, Universitair Medisch Centrum Rotterdam742
已完成
不适用
Randomised trial of haloperidol for delirium in critically ill patientsNL-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 HospitalIRCT20200803048288N1Ahvaz University of Medical Sciences60
尚未招募
不适用
Haloperidol midazolam versus ketamine midazolam in agitated patientsagitation.agitationIRCT20120130008872N13Tehran University of Medical Sciences70