Rivastigmine for Intensive Care Unit (ICU) Delirium
- Registration Number
- NCT00704301
- Lead Sponsor
- UMC Utrecht
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 104
- 18 years or older
- Positive CAM-ICU
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Placebo: 2 times a day 1 Rivastigmine Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. 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.
- Primary Outcome Measures
Name Time Method Duration of delirium 3 months
- Secondary Outcome Measures
Name Time Method Severity of delirium 3 months 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 Length of in-hospital stay 3 months Cognitive outcomes 3 months Activity of daily living 3 months Healthcare costs 3 months Frequency and distribution of side effects 3 months
Trial Locations
- Locations (6)
Medical Center Leeuwarden
🇳🇱Leeuwarden, Friesland, Netherlands
Gelre Hospitals; lukas site
🇳🇱Apeldoorn, Gelderland, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Diakonessenhuis
🇳🇱Utrecht, Netherlands
Medical Center Alkmaar
🇳🇱Alkmaar, Noord-Holland, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands