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 |
| Secondary identifying numbers | 3 |
- 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
Scientific
2nd Floor
Education and Research Centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rivastigmine |
| Primary outcome measure | 1. If develops delirium as found on Confusion Assessment Method 2. Length of delirium, measured in days |
| Secondary outcome measures | 1. Length of admission 2. Change in mini-mental state examination score 3. Use of other psychotropic medication during treatment e.g. benzodiazepines |
| Overall study start date | 01/04/2004 |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
2nd Floor
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
South Manchester University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Industry
Novartis (UK) - paid for tablets only
No information available
South Manchester University Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
