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

BMC Geriatrics

Study Protocol

Eirik Qvigstad¹  Vegard Bruun Wyller²  Alasdair MJ MacLullich³  Bjørn Erik Neerland⁴  Karen Roksund Hov⁵  Torgeir Bruun Wyller⁵  Eva Skovlund⁶ 

[1] Department of Cardiology, Oslo University Hospital, Oslo, Norway;Department of Pediatrics, Akershus University Hospital, Lørenskog, Norway;Institute of Clinical Medicine, University of Oslo, Oslo, Norway;Edinburgh Delirium Research Group, Geriatric Medicine, University of Edinburgh, Room F1424, Royal Infirmary of Edinburgh, 51 Little France Crescent, EH16 4SA, Edinburgh, UK;Oslo Delirium Research Group, Department of Geriatric Medicine, University of Oslo, N-0424, Pb 4956, Oslo, Norway;Oslo Delirium Research Group, Department of Geriatric Medicine, University of Oslo, N-0424, Pb 4956, Oslo, Norway;Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway;School of Pharmacy, University of Oslo, Oslo, Norway;

关键词: Delirium;    Treatment;    Clonidine;    Drug therapy;    Double-blind method;    Aged;    Therapeutic use;    Adrenergic alpha-2 Receptor Agonists;   

DOI  :  10.1186/s12877-015-0006-3

 received in 2014-04-30, accepted in 2015-01-23,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundDelirium 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/DesignThe 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.DiscussionLUCID will explore the efficacy and safety of clonidine for delirium in older medical inpatients.Trial registrationClinicalTrials.gov NCT01956604. EudraCT Number: 2013-000815-26

【 授权许可】

CC BY   
© Neerland et al.; licensee BioMed Central. 2015