Clinical trial NCT00704301: Rivastigmine for Intensive Care Unit (ICU) Delirium
Official title: Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Delirium
Keywords: Delirium
Confusion
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Novartis
name: Netherlands Brain Foundation
First posted: 2008-06-24
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Duration of delirium
timeFrame: 3 months
Secondary outcomes:
measure: Severity of delirium
timeFrame: 3 months
measure: Use of physical restraints
timeFrame: 3 months
measure: Use of escape medication (i.c. Haloperidol or benzodiazepines)
timeFrame: 3 months
measure: Number of accidental removed catheters
timeFrame: 3 months
measure: Length of ICU stay
timeFrame: 3 months
measure: Length of in-hospital stay
timeFrame: 3 months
measure: Cognitive outcomes
timeFrame: 3 months
measure: Activity of daily living
timeFrame: 3 months
measure: Healthcare costs
timeFrame: 3 months
measure: Frequency and distribution of side effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
state: Friesland
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals; lukas site
state: Gelderland
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: University Medical Center Utrecht, the Netherlands
name: Arjen JC Slooter, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Eijk MM, Roes KC, Honing ML, Kuiper MA, Karakus A, van der Jagt M, Spronk PE, van Gool WA, van der Mast RC, Kesecioglu J, Slooter AJ. Effect of rivastigmine as an adjunct to usual care with haloperidol on duration of delirium and mortality in critically ill patients: a multicentre, double-blind, placebo-controlled randomised trial. Lancet. 2010 Nov 27;376(9755):1829-37. doi: 10.1016/S0140-6736(10)61855-7. Epub 2010 Nov 4.