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| Sponsors and Collaborators: |
UMC Utrecht ZonMw: The Netherlands Organisation for Health Research and Development Novartis Hersenstichting |
|---|---|
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00704301 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Delirium |
Drug: Rivastigmine Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Rivastigmine for Delirium in Intensive Care Patients, a Double-Blind, Randomized Placebo-Controlled Add-on Trial |
| Estimated Enrollment: | 440 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
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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.
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2: Placebo Comparator
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: 3 times a day
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Drug: Placebo
Placebo, 3 times a day
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Arjen JC Slooter, MD., PhD. | 31-88-755-3261 | a.slooter-3@umcutrecht.nl |
| Contact: Maarten MJ van Eijk, MD. | 31-64-149-9090 | m.vaneijk-4@umcutrecht.nl |
| Netherlands | |
| University Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands, 3508 GA | |
| Contact: Arjen JC Slooter, MD. PhD. 31-88-755-3261 a.slooter-3@umcutrecht.nl | |
| Contact: Maarten MJ van Eijk, MD. 31-88-755-3261 m.vaneijk-4@umcutrecht.nl | |
| Principal Investigator: Arjen JC Slooter, MD. PhD. | |
| Sub-Investigator: Maarten MJ van Eijk, MD. | |
| Netherlands, Friesland | |
| Medical Center Leeuwarden | Recruiting |
| Leeuwarden, Friesland, Netherlands, 8901 BR | |
| Contact: Michael I Kuiper, MD. PhD. m.i.kuiper@wxs.nl | |
| Contact: Matty Koopmans, RN Matty.Koopmans@ZNB.NL | |
| Principal Investigator: Michael I Kuiper, MD. PhD. | |
| Netherlands, Noord-Holland | |
| Medical Center Alkmaar | Not yet recruiting |
| Alkmaar, Noord-Holland, Netherlands, 1800 AM | |
| Contact: Marina LH Honing, MD. PhD. m.l.h.honing@mca.nl | |
| Contact: Arnoud C Toornvliet, MD. PhD. a.toornvliet@mca.nl | |
| Principal Investigator: Marina LH Honing, MD. PhD. | |
| Sub-Investigator: Arnoud C Toornvliet, MD. PhD. | |
| Netherlands, Zuid-Holland | |
| Erasmus Medical Center | Not yet recruiting |
| Rotterdam, Zuid-Holland, Netherlands, 3000 CA | |
| Contact: Ben van der Hoven, MD. PhD. b.vanderhoven.1@erasmusmc.nl | |
| Contact: Wieneke Hettinga, RN a.hettinga@erasmusmc.nl | |
| Sub-Investigator: Ben van der Hoven, MD. PhD. | |
| Principal Investigator: Jan Bakker, MD. PhD. | |
| Principal Investigator: | Arjen JC Slooter, MD. PhD. | University Medical Center Utrecht, the Netherlands |
More Information
| Responsible Party: | university Medical Center Utrecht, the Netherlands ( Dr. A.J.C. Slooter ) |
| Study ID Numbers: | IC-DEL/006 |
| Study First Received: | June 20, 2008 |
| Last Updated: | December 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00704301 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Delirium Confusion |
|
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Rivastigmine Mental Disorders Neurologic Manifestations |
Confusion Dementia Neurobehavioral Manifestations Cognition Disorders Delirium |
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