Rivastigmine in the Management of Delirium (confuriv)
Primary Purpose
Delirium
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Rivastigmine transdermal patch
placebo patch
Sponsored by
About this trial
This is an interventional treatment trial for Delirium focused on measuring Delirium, acetylcholinesterase inhibitor, Elderly, Emergency department
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Pitié Salpetriere Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rivastigmine transdermal patch
placebo
Arm Description
Outcomes
Primary Outcome Measures
Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care
Secondary Outcome Measures
Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
Percentage of patients with persistent delirium symptoms at day 30 (CAM scale)
Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria)
Full Information
NCT ID
NCT01487317
First Posted
December 5, 2011
Last Updated
July 19, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01487317
Brief Title
Rivastigmine in the Management of Delirium
Acronym
confuriv
Official Title
A Randomized, Double-blind, Placebo-controlled Study of an Acetylcholinesterase Inhibitor in the Management of Delirium in Hospitalized Patients Aged 75 Years and Over
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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, double-blind, placebo-controlled study during one month and a 11-month follow-up
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 undiagnosed cognitive impairment are at risk to develop delirium. In a prospective study, half of elderly patients with delirium seen in the emergency department had cognitive impairment.
Hypothesis: cholinesterase inhibitors reduce duration and severity of delirium
Main objective:
- to assess the efficacy of cholinesterase inhibitors in patients aged 75 and over hospitalized with delirium
Secondary objectives:
to describe at one year the percentage of these patients who have a diagnosis of Alzheimer's disease and associated disorders
to assess the sensitivity to cholinesterase inhibitors in the sub-group of patients with a diagnosis of dementia at one year Design and methods Multicenter, randomized, controlled study with two parallel arms: a rivastigmine group and a placebo group. The study includes a treatment period of one month and a follow-up of 11 months.
Evaluation of the delirium severity will be conducted with DRS-R98 severity each day during the hospitalization.
At day 14, according to DRS-R98 severity score, interruption of treatment or upward dose titration At day 30, last treatment (active or placebo) administration and evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria. In case of dementia diagnosis, investigator (MD) will identify the etiologic diagnosis.
At month 3 and 12, evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria, number of consultation and hospitalization. In case of dementia diagnosis, , investigator (MD) will identify the etiologic diagnosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, acetylcholinesterase inhibitor, Elderly, Emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivastigmine transdermal patch
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rivastigmine transdermal patch
Intervention Description
One transdermal patch of Rivastigmine (equivalent to 4.6 mg/24h per os) per day from randomization to day 14 before day 14: end od treatment, if DRS R-98 severity < 10 during 2 consecutive days At day 14, if DRS R-98 severity ≥ 10: one transdermal patch of Rivastigmine 9.5 mg/24h per day from day 14 to day 30 if DRS R-98 severity < 10, the active treatment will be stopped
Intervention Type
Drug
Intervention Name(s)
placebo patch
Intervention Description
One transdermal patch of placebo per day from randomization to day 14 Before day 14: end of treatment if DRS R-98 severity < 10 during 2 consecutive days, At day 14 if DRS R-98 severity ≥ 10: One transdermal patch of placebo per day from day 14 to day 30 if DRS R-98 severity < 10, the placebo treatment will be stopped
Primary Outcome Measure Information:
Title
Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care
Time Frame
to a maximum of 12 months
Secondary Outcome Measure Information:
Title
Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
Time Frame
at day 14
Title
Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
Time Frame
at day 30
Title
Percentage of patients with persistent delirium symptoms at day 30 (CAM scale)
Time Frame
at day 30
Title
Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria)
Time Frame
at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Verny, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pitié Salpetriere Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
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Rivastigmine in the Management of Delirium
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