Pharmacologic Evaluation of Intravenous Haloperidol for the Treatment of Delirium in Critically Ill Adults

Pharmacologic Evaluation of Intravenous Haloperidol for the Treatment of Delirium in Critically Ill Adults - Pharmacologics of Haloperidol

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40833

Enrollment

Registered

2014-07-21

Start date

2014-05-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute confusional state agitation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
The primary outcome of this study is to assess whether the maximum ICDSC score achieved each day are related to PK parameters of haloperidol in ICU patients with delirium.	—

Secondary

Measure	Time frame
- To characterize the association between daily haloperidol serum levels and the resolution of individual delirium symptoms as measured by the daily ICDSC score. - To characterize the association between daily haloperidol serum levels and the development of each of the following adverse events: a) any increase in the QTc interval from baseline, b) development of akathisia or other extrapyramidal symptoms and c) comedication. This association will be characterized over time. - To investigate in-patient variability of daily serum levels of scheduled IV haloperidol therapy and explore patient factors that might influence the therapeutic levels achieved. Patients factors that will be evaluated: age, BMI, gender, APACHE-IV score, co-medication and SOFA-score. - To investigate the influence of CYP3A4 and CYP2D6 genotype on haloperidol serum levels	—

Measure

Time frame

- To characterize the association between daily haloperidol serum levels and the resolution of individual delirium symptoms as measured by the daily ICDSC score. - To characterize the association between daily haloperidol serum levels and the development of each of the following adverse events: a) any increase in the QTc interval from baseline, b) development of akathisia or other extrapyramidal symptoms and c) comedication. This association will be characterized over time. - To investigate in-patient variability of daily serum levels of scheduled IV haloperidol therapy and explore patient factors that might influence the therapeutic levels achieved. Patients factors that will be evaluated: age, BMI, gender, APACHE-IV score, co-medication and SOFA-score. - To investigate the influence of CYP3A4 and CYP2D6 genotype on haloperidol serum levels

—

Countries

Netherlands

Outcome results