Evaluation of Delirium Prevention in Critically Ill Patients
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
|Study Design:||Observational Model: Case Control|
|Official Title:||Evaluation Study of a Delirium Prevention Policy Using Prophylactic Haloperidol in Critically Ill Patients With a High Risk for Delirium|
- Delirium incidence [ Time Frame: one year ] [ Designated as safety issue: Yes ]Delirium is diagnosed as minimal one positive CAM-ICU screening during complete ICU admission. Incidence rate is compared with historical cohort data
- 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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]measured prospectively and determined in a CRF and compared with historical cohort data
- Effect haloperidol on biomarkers [ Time Frame: one year ] [ Designated as safety issue: No ]Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol
|Study Start Date:||August 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Haloperidol prevention group
ICU patients with a high risk for delirium who are treated with haloperidol for preventive reason.
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187667
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500HB|
|Principal Investigator:||Peter Pickkers, MD, PhD||Radboud University|