NCT00704301

Rivastigmine for Intensive Care Unit (ICU) Delirium

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Delirium

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo, 2 times a day

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2008-06-24
• Last updated: 2010-08-13

Locations

6 sites across 1 country: Netherlands