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
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 |
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
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 |
Observational Model: Case Control
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University Nijmegen Medical Centre | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
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 |
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