Evaluation of Delirium Prevention in Critically Ill Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01187667

Enrollment

650

Registered

2010-08-24

Start date

2010-08-31

Completion date

2011-10-31

Last updated

2012-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

delirium, prevention, critical care, haloperidol

Brief summary

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

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	one year	measured prospectively and determined in a CRF and compared with historical cohort data
Effect haloperidol on biomarkers	one year	Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol

Countries

Netherlands

Outcome results