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Completed

NCT Number: NCT01187667

Evaluation of Delirium Prevention in Critically Ill Patients

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

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. Effect haloperidol on biomarkers

    Time frame: one year

    Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 24, 2010
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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