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

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-adre...

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Autores principales: Neerland, Bjørn Erik, Hov, Karen Roksund, Bruun Wyller, Vegard, Qvigstad, Eirik, Skovlund, Eva, MacLullich, Alasdair MJ, Bruun Wyller, Torgeir
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4336683/
https://www.ncbi.nlm.nih.gov/pubmed/25887557
http://dx.doi.org/10.1186/s12877-015-0006-3
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author Neerland, Bjørn Erik
Hov, Karen Roksund
Bruun Wyller, Vegard
Qvigstad, Eirik
Skovlund, Eva
MacLullich, Alasdair MJ
Bruun Wyller, Torgeir
author_facet Neerland, Bjørn Erik
Hov, Karen Roksund
Bruun Wyller, Vegard
Qvigstad, Eirik
Skovlund, Eva
MacLullich, Alasdair MJ
Bruun Wyller, Torgeir
author_sort Neerland, Bjørn Erik
collection PubMed
description 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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spelling pubmed-43366832015-02-23 The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial Neerland, Bjørn Erik Hov, Karen Roksund Bruun Wyller, Vegard Qvigstad, Eirik Skovlund, Eva MacLullich, Alasdair MJ Bruun Wyller, Torgeir BMC Geriatr Study Protocol 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 BioMed Central 2015-02-10 /pmc/articles/PMC4336683/ /pubmed/25887557 http://dx.doi.org/10.1186/s12877-015-0006-3 Text en © Neerland et al.; licensee BioMed Central. 2015 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Neerland, Bjørn Erik
Hov, Karen Roksund
Bruun Wyller, Vegard
Qvigstad, Eirik
Skovlund, Eva
MacLullich, Alasdair MJ
Bruun Wyller, Torgeir
The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial
title The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial
title_full The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial
title_fullStr The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial
title_full_unstemmed The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial
title_short The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial
title_sort protocol of the oslo study of clonidine in elderly patients with delirium; lucid: a randomised placebo-controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4336683/
https://www.ncbi.nlm.nih.gov/pubmed/25887557
http://dx.doi.org/10.1186/s12877-015-0006-3
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