Delirium
Conditions
Keywords
Delirium, Confusion
Brief summary
Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.
Detailed description
Objective: To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs. Study design: Multicentre, double-blind, randomized controlled trial. Study population: Consecutive adult ICU patients with delirium according to the CAM-ICU. Intervention: Increasing dosage of rivastigmine or placebo as add-on medication. Primary study parameters: Duration of delirium. Secondary study parameters: Delirium severity, length of ICU and hospital stay, functional status and mortality after 3 months. Sample size: 440 patients will be included. Economic evaluation: includes a comparison of direct and indirect medical costs. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden: questionnaires (duration: 30 minutes). Risk: possible exposure to drug not indicated for the disorder. Benefit: possible treatment with according to experts possible beneficial drug. Consideration: The investigators of this study believe that the burden and risk do not exceed the expected benefit.
Interventions
DRUGRivastigmine
Rivastigmine, two times 1,5 mg a day. The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day.
DRUGPlacebo
Placebo, 2 times a day
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Novartis
Netherlands Brain Foundation
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Positive CAM-ICU
Exclusion criteria
* Known allergy to rivastigmine * Unable to receive enteric medication * Pregnant or lactating * Renal replacement therapy * Hepatic encephalopathy * Second or third degree atrioventricular block * Uncertainty about diagnosis delirium and no confirmation by neurologist, psychiatrist or geriatrician * Parkinson's disease. * Lewy body dementia. * ECG QT interval above 500 msec. * No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of delirium | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Use of physical restraints | 3 months |
| Use of escape medication (i.c. Haloperidol or benzodiazepines) | 3 months |
| Number of accidental removed catheters | 3 months |
| Length of ICU stay | 3 months |
| Severity of delirium | 3 months |
| Cognitive outcomes | 3 months |
| Activity of daily living | 3 months |
| Healthcare costs | 3 months |
| Frequency and distribution of side effects | 3 months |
| Length of in-hospital stay | 3 months |
Countries
Netherlands
Outcome results
None listed