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Published in: BMC Geriatrics 1/2015

Open Access 01-12-2015 | Study protocol

The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial

Authors: Bjørn Erik Neerland, Karen Roksund Hov, Vegard Bruun Wyller, Eirik Qvigstad, Eva Skovlund, Alasdair MJ MacLullich, Torgeir Bruun Wyller

Published in: BMC Geriatrics | Issue 1/2015

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Abstract

Background

Delirium affects 15% of hospitalised patients and is linked with poor outcomes, yet few pharmacological treatment options exist. One hypothesis is that delirium may in part result from exaggerated and/or prolonged stress responses. Dexmedetomidine, a parenterally-administered alpha2-adrenergic receptor agonist which attenuates sympathetic nervous system activity, shows promise as treatment in ICU delirium. Clonidine exhibits similar pharmacodynamic properties and can be administered orally. We therefore wish to explore possible effects of clonidine upon the duration and severity of delirium in general medical inpatients.

Methods/Design

The Oslo Study of Clonidine in Elderly Patients with Delirium (LUCID) is a randomised, placebo-controlled, double-blinded, parallel group study with 4-month prospective follow-up. We will recruit 100 older medical inpatients with delirium or subsyndromal delirium in the acute geriatric ward. Participants will be randomised to oral clonidine or placebo until delirium free for 2 days (Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria), or after a maximum of 7 days treatment. Assessment of haemodynamics (blood pressure, heart rate and electrocardiogram) and delirium will be performed daily until discharge or a maximum of 7 days after end of treatment. The primary endpoint is the trajectory of delirium over time (measured by Memorial Delirium Assessment Scale). Secondary endpoints include the duration of delirium, use of rescue medication for delirium, pharmacokinetics and pharmacodynamics of clonidine, cognitive function after 4 months, length of hospital stay and need for institutionalisation.

Discussion

LUCID will explore the efficacy and safety of clonidine for delirium in older medical inpatients.

Trial registration

ClinicalTrials.gov NCT01956604. EudraCT Number: 2013-000815-26
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Metadata
Title
The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial
Authors
Bjørn Erik Neerland
Karen Roksund Hov
Vegard Bruun Wyller
Eirik Qvigstad
Eva Skovlund
Alasdair MJ MacLullich
Torgeir Bruun Wyller
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Geriatrics / Issue 1/2015
Electronic ISSN: 1471-2318
DOI
https://doi.org/10.1186/s12877-015-0006-3

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