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
1 other identifier
observational
650
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 23, 2010
CompletedFirst Posted
Study publicly available on registry
August 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedAugust 10, 2012
August 1, 2012
1 year
August 23, 2010
August 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delirium incidence
Delirium is diagnosed as minimal one positive CAM-ICU screening during complete ICU admission. Incidence rate is compared with historical cohort data
one year
Secondary Outcomes (2)
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
one year
Effect haloperidol on biomarkers
one year
Study Arms (2)
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.
Eligibility Criteria
Patients admitted in the ICU of a tertiary care clinic
You may qualify if:
- Patients With Predicted Delirium Chance of \>50% or history of dementia or alcohol abuse and treated with haloperidol
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB, Netherlands
Related Publications (1)
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.
PMID: 23327295DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Pickkers, MD, PhD
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
August 23, 2010
First Posted
August 24, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
October 1, 2011
Last Updated
August 10, 2012
Record last verified: 2012-08