We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Evaluation of Delirium Prevention in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01187667
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : August 10, 2012
Information provided by (Responsible Party):

August 23, 2010
August 24, 2010
August 10, 2012
August 2010
August 2011   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01187667 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
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
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

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

Observational Model: Case Control
Not Provided
Not Provided
Non-Probability Sample
Patients admitted in the ICU of a tertiary care clinic
Not Provided
  • Haloperidol prevention group
    ICU patients with a high risk for delirium who are treated with haloperidol for preventive reason.
  • Control group
    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.
van den Boogaard M, Schoonhoven L, van Achterberg T, van der Hoeven JG, Pickkers P. Haloperidol prophylaxis in critically ill patients with a high risk for delirium. Crit Care. 2013 Jan 17;17(1):R9. doi: 10.1186/cc11933.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Mark van den Boogaard, Radboud University
Radboud University
Not Provided
Principal Investigator: Peter Pickkers, MD, PhD Radboud University
Radboud University
August 2012