Trial | NCT00704301  Report issue

Title

Rivastigmine for Intensive Care Unit (ICU) Delirium
Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    rivastigmine ...

  • Study Participants

    104
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.
Study Started
Nov 30
2008
Primary Completion
Apr 30
2010
Study Completion
May 31
2010
Last Update
Aug 13
2010
Estimate

Drug Placebo

Placebo, 2 times a day

Drug Rivastigmine

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 names: Exelon

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

Criteria 

Inclusion Criteria:

18 years or older
Positive CAM-ICU

Exclusion Criteria:

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
No Results Posted