Evaluation of Delirium Prevention in Critically Ill Patients

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187667
• Other study ID #: 2010/May
• Status: Completed
• Phase: N/A
• First received: August 23, 2010
• Last updated: August 9, 2012
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: August 2012
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	measured prospectively and determined in a CRF and compared with historical cohort data	one year	Yes
Secondary	Effect haloperidol on biomarkers	Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol	one year	No