Evaluation of Delirium Prevention in Critically Ill Patients

August 9, 2012 updated by: Mark van den Boogaard, Radboud University Medical Center

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

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500HB
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted in the ICU of a tertiary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year
Effect haloperidol on biomarkers
Time Frame: one year
Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Peter Pickkers, MD, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (Estimate)

August 24, 2010

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 9, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/May

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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