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Rivastigmine for Intensive Care Unit (ICU) Delirium

Sponsor
UMC Utrecht (Other)
Overall Status
Terminated
CT.gov ID
NCT00704301
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other), Novartis (Industry), Netherlands Brain Foundation (Other)
104
Enrollment
6
Locations
2
Arms
17.9
Duration (Months)
17.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial
Study Start Date :
Nov 1, 2008
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. 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: 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.
Other Names:
  • Exelon

    		•
    Placebo Comparator: 2

    Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Placebo: 2 times a day

    Drug: Placebo
    Placebo, 2 times a day

    Outcome Measures

    Primary Outcome Measures

    1. Duration of delirium [3 months]

    Secondary Outcome Measures

    1. Severity of delirium [3 months]

    2. Use of physical restraints [3 months]

    3. Use of escape medication (i.c. Haloperidol or benzodiazepines) [3 months]

    4. Number of accidental removed catheters [3 months]

    5. Length of ICU stay [3 months]

    6. Length of in-hospital stay [3 months]

    7. Cognitive outcomes [3 months]

    8. Activity of daily living [3 months]

    9. Healthcare costs [3 months]

    10. Frequency and distribution of side effects [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Center Leeuwarden Leeuwarden Friesland Netherlands 8901 BR
    2 Gelre Hospitals; lukas site Apeldoorn Gelderland Netherlands 7300 DS
    3 Medical Center Alkmaar Alkmaar Noord-Holland Netherlands 1800 AM
    4 Erasmus Medical Center Rotterdam Zuid-Holland Netherlands 3000 CA
    5 University Medical Center Utrecht Utrecht Netherlands 3508 GA
    6 Diakonessenhuis Utrecht Netherlands 3582 KE

    Sponsors and Collaborators

    • UMC Utrecht
    • ZonMw: The Netherlands Organisation for Health Research and Development
    • Novartis
    • Netherlands Brain Foundation

    Investigators

    • Principal Investigator: Arjen JC Slooter, MD. PhD., University Medical Center Utrecht, the Netherlands

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00704301
    Other Study ID Numbers:
    • IC-DEL/009
    First Posted:
    Jun 24, 2008
    Last Update Posted:
    Aug 13, 2010
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    Delirium
    Confusion
    Additional relevant MeSH terms:
    Delirium
    Rivastigmine

    Study Results

    No Results Posted as of Aug 13, 2010