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Evaluation of Delirium Prevention in Critically Ill Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark van den Boogaard, Radboud University
ClinicalTrials.gov Identifier:
NCT01187667
First received: August 23, 2010
Last updated: August 9, 2012
Last verified: August 2012
History of Changes

August 23, 2010
August 9, 2012
August 2010
August 2011   (final data collection date for primary outcome measure)
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
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 ] [ 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
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
Observational Model: Case Control
Not Provided
Not Provided
Non-Probability Sample

Patients admitted in the ICU of a tertiary care clinic
Delirium
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01187667
2010/May
No
Mark van den Boogaard, Radboud University
Radboud University
Not Provided
Principal Investigator: Peter Pickkers, MD, PhD Radboud University
Radboud University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP