A randomised placebo-controlled trial of rivastigmine in delirium in older medical in-patients: a pilot study

ISRCTN	ISRCTN27327721
DOI	https://doi.org/10.1186/ISRCTN27327721
Protocol serial number	3
Sponsor	South Manchester University Hospitals NHS Trust (UK)
Funders	Novartis (UK) - paid for tablets only, South Manchester University Hospitals NHS Trust (UK)

Submission date: 12/09/2005
Registration date: 28/10/2005
Last edited: 14/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alistair Burns
Scientific

2nd Floor
Education and Research Centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. The duration of delirium in people aged 65 or over on admission to an acute medical care of the elderly ward, or with onset at any time 3 weeks after admission, will be significantly less when treated with rivastigmine up to 3 mg daily compared to placebo, whether or not supplemented by risperidone 1 mg in divided doses daily 2. The proportion of older people who develop a delirium postoperatively following an orthopaedic procedure will be significantly less when treated with rivastigmine up to 3 mg daily compared to placebo, whether or not supplemented by risperidone 1 mg in divided doses daily 3. The percentage of patients who experience adverse events or complications on rivastigmine compared to placebo will be significantly less than those receiving treatment as usual 4. The percentage of patients who relapse after three delirium-free days after an episode of delirium will be significantly higher in those previously treated as usual than those treated with rivastigmine 5. These differences will remain significant irrespective of pre-admission cognitive function
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Delirium
Intervention	Rivastigmine up to 1.5 mg twice a day or placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Rivastigmine
Primary outcome measure(s)	1. If develops delirium as found on Confusion Assessment Method 2. Length of delirium, measured in days
Key secondary outcome measure(s)	1. Length of admission 2. Change in mini-mental state examination score 3. Use of other psychotropic medication during treatment e.g. benzodiazepines
Completion date	01/07/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Patients over 65 years old 2. Admitted to elderly acute medical ward or orthopaedic ward 3. Patient has a delirium as measured on the Confusion Assessment Method or doesn't have a delirium and has a fractured neck of femur caused by trauma
Key exclusion criteria	1. Patient already on cholinesterase inhibitor 2. Patient has had a previous adverse reaction to a cholinesterase inhibitor 3. If considered by medical team in charge of care to be in the terminal phase of illness 4. Acute chronic obstructive pulmonary disease (COPD) or asthma 5. Has a dysrhythmia on electrocardiogram (ECG) 6. Urea >20 or creatinine >200
Date of first enrolment	01/04/2004
Date of final enrolment	01/07/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

2nd Floor

Manchester
M23 9LT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2010		Yes	No