Evaluation of Delirium Prevention in Critically Ill Patients
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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 |
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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 |
- 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
- 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 |
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Haloperidol prevention group
ICU patients with a high risk for delirium who are treated with haloperidol for preventive reason.
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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.
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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 |
Patients admitted in the ICU of a tertiary care clinic
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 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:
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delirium prevention critical care haloperidol |
Additional relevant MeSH terms:
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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 May 23, 2013