Rivastigmine for Intensive Care Unit (ICU) Delirium
|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|
|Primary Completion Date :||April 2010|
|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 ]
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|