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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00704301
Other study ID # IC-DEL/009
Secondary ID
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


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
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