Clinical Trial: Rivastigmine for Intensive Care Unit (ICU) Delirium

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: UMC Utrecht

Current Primary Outcome: Duration of delirium [ Time Frame: 3 months ]

Original Primary Outcome: Duration of delirium [ Time Frame: end of delirium ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Severity of delirium [ Time Frame: during delirium ]
  • Use of physical restraints [ Time Frame: duration of ICU stay ]
  • Use of escape medication (i.c. Haloperidol or benzodiazepines) [ Time Frame: duration of ICU stay ]
  • Number of accidental removed catheters [ Time Frame: duration of ICU stay ]
  • Length of ICU stay [ Time Frame: duration of ICU stay ]
  • Length of in-hospital stay [ Time Frame: duration of admission ]
  • Cognitive outcomes [ Time Frame: 90 days ]
  • Activity of daily living [ Time Frame: 90 days ]
  • Healthcare costs [ Time Frame: 90 days ]
  • Frequency and distribution of side effects [ Time Frame: duration of ICU stay ]


Information By: UMC Utrecht

Dates:
Date Received: June 20, 2008
Date Started: November 2008
Date Completion:
Last Updated: August 12, 2010
Last Verified: October 2009