Evaluation of Delirium Prevention in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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

Conditions

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Delirium

Keywords

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delirium prevention critical care haloperidol

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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Haloperidol prevention group

ICU patients with a high risk for delirium who are treated with haloperidol for preventive reason.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Mark van den Boogaard

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Pickkers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED

PMID: 23327295 (View on PubMed)

Other Identifiers

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2010/May

Identifier Type: -

Identifier Source: org_study_id