Evaluation of Delirium Prevention in Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT01187667|
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : August 10, 2012
|Condition or disease|
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
|Study Type :||Observational|
|Actual Enrollment :||650 participants|
|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|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||October 2011|
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.
- Delirium incidence [ Time Frame: one year ]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 ]measured prospectively and determined in a CRF and compared with historical cohort data
- Effect haloperidol on biomarkers [ Time Frame: one year ]Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187667
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500HB|
|Principal Investigator:||Peter Pickkers, MD, PhD||Radboud University|