Status:
COMPLETED
Rivastigmine in the Management of Delirium
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Delirium
Eligibility:
All Genders
75+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium. Study type : Interventional Study design: randomized, do...
Detailed Description
Delirium affects up to 50% of hospitalized patients aged 75 and over. Delirium increases risk of comorbid illness, hospital length of stay, institutionalization, and death. Patients with diagnosed or ...
Eligibility Criteria
Inclusion
- Patients aged 75 and over
- Hospitalization for delirium not correlated to surgery for less than 48 hours
- Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of consciousness) of the Confusion Assessment Model and DRS R-98 \> 10
- Absence of any contraindications to a cholinesterase inhibitor treatment
- Health insurance affiliation
- Having signed an informed consent form
- Caregiver/informant to provide information on patient
Exclusion
- Use of IAchE or memantine medication
- Contraindication to IAchE medication
- Frontotemporal dementia
- Diseases involving the short-term survival
- Digestive bleeding
- Ischemic and hemorrhagic stroke related to actual onset (including hemorrhagic contusion)
- Natremia ≤120 mmol/l at the time of hospitalization
- Post epileptic confusion
- Hepato-cellular failure
- Cardiorespiratory impairment at risk of transfer to intensive care unit
- Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
- Not fluent in French
- Being under guardianship
- Absence of caregiver/informant to sign informed consent form
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01487317
Start Date
June 1 2011
End Date
February 1 2016
Last Update
July 20 2016
Active Locations (1)
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1
Pitié Salpetriere Hospital
Paris, France, 75013