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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. Identifier: NCT01187667
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : August 10, 2012
Information provided by (Responsible Party):
Mark van den Boogaard, Radboud University

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

Condition or disease

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. Effect haloperidol on biomarkers [ Time Frame: one year ]
    Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted in the ICU of a tertiary care clinic

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01187667

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Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
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Principal Investigator: Peter Pickkers, MD, PhD Radboud University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mark van den Boogaard, PhD, Radboud University Identifier: NCT01187667     History of Changes
Other Study ID Numbers: 2010/May
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Mark van den Boogaard, Radboud University:
critical care

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Haloperidol decanoate
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents