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The study is prematurely terminated due to a safety issue
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Novartis | INDUSTRY |
| Netherlands Brain Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
|
| 2 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of delirium | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of delirium | 3 months | |
| Use of physical restraints | 3 months | |
| Use of escape medication (i.c. Haloperidol or benzodiazepines) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arjen JC Slooter, MD. PhD. | University Medical Center Utrecht, the Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelre Hospitals; lukas site | Apeldoorn | Gelderland | 7300 DS | Netherlands | ||
| Medical Center Alkmaar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21056464 | Derived | van Eijk MM, Roes KC, Honing ML, Kuiper MA, Karakus A, van der Jagt M, Spronk PE, van Gool WA, van der Mast RC, Kesecioglu J, Slooter AJ. Effect of rivastigmine as an adjunct to usual care with haloperidol on duration of delirium and mortality in critically ill patients: a multicentre, double-blind, placebo-controlled randomised trial. Lancet. 2010 Nov 27;376(9755):1829-37. doi: 10.1016/S0140-6736(10)61855-7. Epub 2010 Nov 4. |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068836 | Rivastigmine |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
| Placebo | Drug | Placebo, 2 times a day |
|
| 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 |
| Alkmaar |
| North Holland |
| 1800 AM |
| Netherlands |
| Medical Center Leeuwarden | Leeuwarden | Provincie Friesland | 8901 BR | Netherlands |
| Erasmus Medical Center | Rotterdam | South Holland | 3000 CA | Netherlands |
| University Medical Center Utrecht | Utrecht | Utrecht | 3508 GA | Netherlands |
| Diakonessenhuis | Utrecht | Utrecht | 3582 KE | Netherlands |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |