Pharmacologic Evaluation of Intravenous Haloperidol for the Treatment of Delirium in Critically Ill Adults
- Conditions
- acute confusional stateagitation10012221
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
- adult patients (>18 years) with a diagnosis of delirium according to the ICDSC (Intensive Care Delirium Screening Checklist from day 1 of ICU treatment or later (or patients with haloperidol at day of admission, without prior treatment of haloperidol).
- expected ICU-stay of > 48 hours,
- scheduled to be treated with IV haloperidol as per the ErasmusMC ICU delirium treatment protocol
- Treatment with haloperidol in the 24 hours before ICU admission
- ICDSC cannot be obtained due to coma
- end stage liver failure
- primary neurologic disease (if ICDSC score cannot be performed)
- history of severe dementia
- history of parkinsonism and/or psychosis
- a baseline QTc > 450msec at admission
- use of medications with known major interaction with haloperidol (i.e. bosentan, carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, nevirapine, primidon, rifabutin, lopinavir, ritonavir and rifampicin), patients with delirium caused by acute alcohol withdrawal
- pregnancy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of this study is to assess whether the maximum ICDSC score<br /><br>achieved each day are related to PK parameters of haloperidol in ICU patients<br /><br>with delirium. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To characterize the association between daily haloperidol serum levels and<br /><br>the resolution of individual delirium symptoms as measured by the daily ICDSC<br /><br>score.<br /><br>- To characterize the association between daily haloperidol serum levels and<br /><br>the development of each of the following adverse events: a) any increase in the<br /><br>QTc interval from baseline, b) development of akathisia or other extrapyramidal<br /><br>symptoms and c) comedication. This association will be characterized over time.<br /><br>- To investigate in-patient variability of daily serum levels of scheduled IV<br /><br>haloperidol therapy and explore patient factors that might influence the<br /><br>therapeutic levels achieved. Patients factors that will be evaluated: age, BMI,<br /><br>gender, APACHE-IV score, co-medication and SOFA-score.<br /><br>- To investigate the influence of CYP3A4 and CYP2D6 genotype on haloperidol<br /><br>serum levels</p><br>