Rivastigmine for Intensive Care Unit (ICU) Delirium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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.

Group Type EXPERIMENTAL

Rivastigmine

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, 2 times a day

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo, 2 times a day

Intervention Type DRUG

Other Intervention Names

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Exelon

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No