Evaluation of Delirium Prevention in Critically Ill Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark van den Boogaard, Radboud University
ClinicalTrials.gov Identifier:
NCT01187667
First received: August 23, 2010
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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


Condition
Delirium

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Evaluation Study of a Delirium Prevention Policy Using Prophylactic Haloperidol in Critically Ill Patients With a High Risk for Delirium

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Delirium incidence [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    measured prospectively and determined in a CRF and compared with historical cohort data

  • Effect haloperidol on biomarkers [ Time Frame: one year ] [ Designated as safety issue: No ]
    Biomarkers are measured in patients with high risk for delirium which are preventively treated with haloperidol


Enrollment: 650
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted in the ICU of a tertiary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187667

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Peter Pickkers, MD, PhD Radboud University
  More Information

No publications provided

Responsible Party: Mark van den Boogaard, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT01187667     History of Changes
Other Study ID Numbers: 2010/May
Study First Received: August 23, 2010
Last Updated: August 9, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
delirium
prevention
critical care
haloperidol

Additional relevant MeSH terms:
Critical Illness
Delirium
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on September 18, 2014