Evaluation of Delirium Prevention in Critically Ill Patients

Study Overview
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Brief Summary
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Haloperidol is prescribed in high risk ICU patients concerning delirium (50% or more chance to develop delirium detected with the delirium prediction model PRE-DELIRIC, or patients with history of dementia or alcohol abuse)since the delirium protocol is changed and haloperidol is added as a prevention treatment we are gathering information what the effect is on several aspects of delirium

Detailed Description
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Measurement the effect of haloperidol as delirium preventive intervention. Determining effect on: - delirium incidence in the ICU - different subtypes of delirium - delirium free days in 28 days - days on the ventilator - length of stay on the ICU and In-Hospital - 28-day mortality - incidence of unexpected removal of tubes, and effect between different groups of patients. Safety of haloperidol concerning QT-time, extrapyramidal symptoms. Data are compared with the data of a historical cohort

Official Title
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Evaluation Study of a Delirium Prevention Policy Using Prophylactic Haloperidol in Critically Ill Patients With a High Risk for Delirium

Conditions
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Delirium

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients With Predicted Delirium Chance of >50% or history of dementia or alcohol abuse and treated with haloperidol Exclusion Criteria: CAM-ICU is Not Applicable Patients Admitted 24hours or Shorter on the ICU, Patients Who Are Delirious Within 24 Hours After ICU Admission patients whereby haloperidol is contra-indicated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Haloperidol prevention group<br>ICU patients with a high risk for delirium who are treated with haloperidol for preventive reason. | |
| Control group<br>Historical cohort group of patients (2008-2009)with a determined risk of 50% or more for delirium who were not treated with haloperidol for preventive reason. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium incidence | Delirium is diagnosed as minimal one positive CAM-ICU screening during complete ICU admission. Incidence rate is compared with historical cohort data | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of delirium days on mechanical ventilator Length of stay in the ICU and in-hospital in-hospital mortality incidence of unplanned removal of tube incidence of delirium subtypes | measured prospectively and determined in a CRF and compared with historical cohort data | one year | 
| Effect haloperidol on biomarkers | Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delirium, prevention, critical care, haloperidol