Rivastigmine for Intensive Care Unit (ICU) Delirium
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|ClinicalTrials.gov Identifier: NCT00704301|
Recruitment Status : Terminated (The study is prematurely terminated due to a safety issue)
First Posted : June 24, 2008
Last Update Posted : August 13, 2010
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Drug: Rivastigmine Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||May 2010|
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.
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.
Other Name: Exelon
Placebo Comparator: 2
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
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704301
|Medical Center Leeuwarden|
|Leeuwarden, Friesland, Netherlands, 8901 BR|
|Gelre Hospitals; lukas site|
|Apeldoorn, Gelderland, Netherlands, 7300 DS|
|Medical Center Alkmaar|
|Alkmaar, Noord-Holland, Netherlands, 1800 AM|
|Erasmus Medical Center|
|Rotterdam, Zuid-Holland, Netherlands, 3000 CA|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Utrecht, Netherlands, 3582 KE|
|Principal Investigator:||Arjen JC Slooter, MD. PhD.||University Medical Center Utrecht, the Netherlands|