Evaluation of Delirium Prevention in Critically Ill Patients

Completed

• Conditions: Delirium

• Registration Number: NCT01187667
• Lead Sponsor: Radboud University Medical Center

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

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-09
• Last Update Posted: 2012-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delirium incidence	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

Name	Time	Method
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	measured prospectively and determined in a CRF and compared with historical cohort data
Effect haloperidol on biomarkers	one year	Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands