Rivastigmine for Intensive Care Unit (ICU) Delirium

UMC Utrecht

Status and phase: Terminated; Phase 4

Conditions: Delirium

Treatments: Drug: Rivastigmine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00704301

IC-DEL/009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Drug: Rivastigmine

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo