Rivastigmine for Intensive Care Unit (ICU) Delirium

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00704301
• Other study ID #: IC-DEL/009
• Status: Terminated
• Phase: Phase 4
• First received: June 20, 2008
• Last updated: August 12, 2010
• Start date: November 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2009
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delirium

Intervention

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.
• Placebo
Placebo, 2 times a day

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar	Alkmaar	Noord-Holland
Netherlands	Gelre Hospitals; lukas site	Apeldoorn	Gelderland
Netherlands	Medical Center Leeuwarden	Leeuwarden	Friesland
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Netherlands	Diakonessenhuis	Utrecht
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	Hersenstichting, Novartis, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of delirium		3 months	No
Secondary	Severity of delirium		3 months	No
Secondary	Use of physical restraints		3 months	No
Secondary	Use of escape medication (i.c. Haloperidol or benzodiazepines)		3 months	No
Secondary	Number of accidental removed catheters		3 months	No
Secondary	Length of ICU stay		3 months	No
Secondary	Length of in-hospital stay		3 months	No
Secondary	Cognitive outcomes		3 months	No
Secondary	Activity of daily living		3 months	No
Secondary	Healthcare costs		3 months	No
Secondary	Frequency and distribution of side effects		3 months	Yes