Status:
TERMINATED
Rivastigmine for Intensive Care Unit (ICU) Delirium
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Novartis
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 du...
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 c...
Eligibility Criteria
Inclusion
- 18 years or older
- Positive CAM-ICU
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00704301
Start Date
November 1 2008
End Date
May 1 2010
Last Update
August 13 2010
Active Locations (6)
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1
Gelre Hospitals; lukas site
Apeldoorn, Gelderland, Netherlands, 7300 DS
2
Medical Center Alkmaar
Alkmaar, North Holland, Netherlands, 1800 AM
3
Medical Center Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands, 8901 BR
4
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3000 CA