No registrations found.
ID
Source
Brief title
Health condition
delirium stroke (dutch; delier beroerte)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of delirium measured with confusion assessment method and delirium rating scal
Secondary outcome
- Duration of delirium
- Other medication needed
Background summary
Background:
Delirium is a common disorder in the early phase of stroke. Given the presumed cholinergic deficiency in delirium, we tested treatment with the acetylcholinesterase inhibitor rivastigmine.
Methods:
This pilot study was performed within an epidemiological study. In 527 consecutive stroke patients presence of delirium was assessed during the first week with the confusion assessment method. Severity was scored with the delirium rating scale (DRS). Sixty-two patients developed a delirium in the acute phase of stroke. Only patients with a severe and persistent delirium were enrolled in the present study. In total 26 fulfilled these criteria of whom 17 were treated with orally administered rivastigmine. Eight patients could not be treated because of dysphagia and one because of early discharge.
Results:
No major side effects were recorded. In 16 patients there was a considerable decrease in severity of delirium. The mean duration of delirium was 6.7 days (range; 2-17).
Conclusions:
Rivastigmine is safe in stroke patients with delirium even after rapid titration. In the majority of patients the delirium improved after treatment. A randomized controlled trial is needed to establish the usefulness of rivastigmine in delirium after stroke.
Study objective
Given the presumed cholinergic deficiency the cholinergic drug rivastigmine might be a suitable drug for treatment of delirium
Study design
- Each treated patient was followed untill the delirium was gone
Intervention
Rivastigmine 1.5 b.i.d, with an increase every other day with 3 mg to a maximum of 6 mg b.i.d
Department of Neurology <br>
PO box 90151
G. Roks
Tilburg 5000 LC
The Netherlands
g.roks@elisabeth.nl
Department of Neurology <br>
PO box 90151
G. Roks
Tilburg 5000 LC
The Netherlands
g.roks@elisabeth.nl
Inclusion criteria
1. Recent stroke
2. Persistent delirium
3. Severe delirium
Exclusion criteria
1. Prior adverse effects of rivastigmine
2. Severe renal failure
3. Age < 18 years
4. Women of child bearing potential
5. Use of any other investigational agent in the last 30 days
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1337 |
NTR-old | NTR1395 |
Other | Medical ethical commitee Tilburg the Netherlands : 0307 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |