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Rivastigmine for Intensive Care Unit (ICU) Delirium

NCT00704301 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2010-08-13

No results posted yet for this study

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.

Conditions

  • Delirium

Interventions

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.

DRUG

Placebo

Placebo, 2 times a day

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Netherlands Brain Foundation

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Arjen JC Slooter, MD. PhD. · University Medical Center Utrecht, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • Netherlands

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704301 on ClinicalTrials.gov