A Phase 4 interventional study of Rivastigmine and Placebo in Delirium, sponsored by UMC Utrecht. Terminated at 6 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-13.
Sponsored by UMC Utrecht · Phase 4, Interventional, and Treatment
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.
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 104 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 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. Placebo: 2 times a day
Drug: Placebo
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.
Also known as: Exelon
Placebo, 2 times a day
Duration of delirium
Time frame: 3 months
Severity of delirium
Time frame: 3 months
Use of physical restraints
Time frame: 3 months
Use of escape medication (i.c. Haloperidol or benzodiazepines)
Time frame: 3 months
Number of accidental removed catheters
Time frame: 3 months
Length of ICU stay
Time frame: 3 months
Length of in-hospital stay
Time frame: 3 months
Cognitive outcomes
Time frame: 3 months
Activity of daily living
Time frame: 3 months
Healthcare costs
Time frame: 3 months
Frequency and distribution of side effects
Time frame: 3 months
This study is terminated, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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UMC Utrecht