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Rivastigmine as a treatment in delirium; a pilot study


- candidate number3798
- NTR NumberNTR1395
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2008
- Secondary IDs0307 Medical ethical commitee Tilburg the Netherlands
- Public TitleRivastigmine as a treatment in delirium; a pilot study
- Scientific TitleDelirium after stroke and treatment with rivastigmine; a pilot study
- ACRONYMN/A
- hypothesisGiven the presumed cholinergic deficiency the cholinergic drug rivastigmine might be a suitable drug for treatment of delirium
- Healt Condition(s) or Problem(s) studiedStroke, Delirium, Stroke, Rivastigmine
- Inclusion criteria1. Recent stroke
2. Persistent delirium
3. Severe delirium
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2004
- planned closingdate1-feb-2005
- Target number of participants20
- InterventionsRivastigmine 1.5 b.i.d, with an increase every other day with 3 mg to a maximum of 6 mg b.i.d
- Primary outcomePresence of delirium measured with confusion assessment method and delirium rating scal
- Secondary outcome- Duration of delirium
- Other medication needed
- Timepoints- Each treated patient was followed untill the delirium was gone
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. G. Roks
- CONTACT for SCIENTIFIC QUERIESDr. G. Roks
- Sponsor/Initiator St. Elisabeth Hospital, Tilburg
- Funding
(Source(s) of Monetary or Material Support)
Novartis
- PublicationsN/A
- Brief summaryBackground:
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.
- Main changes (audit trail)
- RECORD5-aug-2008 - 12-aug-2008


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