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Clinical Trials/NCT01187667
NCT01187667
Completed
Not Applicable

Evaluation Study of a Delirium Prevention Policy Using Prophylactic Haloperidol in Critically Ill Patients With a High Risk for Delirium

Radboud University Medical Center1 site in 1 country650 target enrollmentAugust 2010
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Radboud University Medical Center
Enrollment
650
Locations
1
Primary Endpoint
Delirium incidence
Status
Completed
Last Updated
13 years ago

Overview

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

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

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
October 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark van den Boogaard

PhD

Radboud University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (1)

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