Cargando…
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...
Autores principales: | , , , , , , |
---|---|
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 |
_version_ | 1782358497873100800 |
---|---|
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 |
format | Online Article Text |
id | pubmed-4336683 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT neerlandbjørnerik theprotocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT hovkarenroksund theprotocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT bruunwyllervegard theprotocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT qvigstadeirik theprotocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT skovlundeva theprotocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT maclullichalasdairmj theprotocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT bruunwyllertorgeir theprotocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT neerlandbjørnerik protocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT hovkarenroksund protocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT bruunwyllervegard protocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT qvigstadeirik protocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT skovlundeva protocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT maclullichalasdairmj protocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial AT bruunwyllertorgeir protocoloftheoslostudyofclonidineinelderlypatientswithdeliriumlucidarandomisedplacebocontrolledtrial |