title: The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial.
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
  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.
  
  
  CONCLUSIONS
  LUCID will explore the efficacy and safety of clonidine for delirium in older medical inpatients.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01956604. EudraCT Number: 2013-000815-26.
authors.affiliation: Oslo Delirium Research Group, Department of Geriatric Medicine, University of Oslo, Pb 4956, N-0424, Oslo, Norway. bjorn.erik@neerland.net.
authors.forename: Bjørn Erik
authors.initials: BE
authors.lastname: Neerland
authors.affiliation: Oslo Delirium Research Group, Department of Geriatric Medicine, University of Oslo, Pb 4956, N-0424, Oslo, Norway. karenroksundhov@gmail.com.|Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway. karenroksundhov@gmail.com.
authors.forename: Karen Roksund
authors.initials: KR
authors.lastname: Hov
authors.affiliation: Department of Pediatrics, Akershus University Hospital, Lørenskog, Norway. brwylle@online.no.|Institute of Clinical Medicine, University of Oslo, Oslo, Norway. brwylle@online.no.
authors.forename: Vegard
authors.initials: V
authors.lastname: Bruun Wyller
authors.affiliation: Department of Cardiology, Oslo University Hospital, Oslo, Norway. eirik.qvigstad@medisin.uio.no.
authors.forename: Eirik
authors.initials: E
authors.lastname: Qvigstad
authors.affiliation: School of Pharmacy, University of Oslo, Oslo, Norway. eva.skovlund@farmasi.uio.no.
authors.forename: Eva
authors.initials: E
authors.lastname: Skovlund
authors.affiliation: Edinburgh Delirium Research Group, Geriatric Medicine, University of Edinburgh, Room F1424, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UK. a.maclullich@ed.ac.uk.
authors.forename: Alasdair M J
authors.initials: AM
authors.lastname: MacLullich
authors.affiliation: Oslo Delirium Research Group, Department of Geriatric Medicine, University of Oslo, Pb 4956, N-0424, Oslo, Norway. t.b.wyller@medisin.uio.no.|Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway. t.b.wyller@medisin.uio.no.
authors.forename: Torgeir
authors.initials: T
authors.lastname: Bruun Wyller
mesh_terms: D058647:Adrenergic alpha-2 Receptor Agonists / Q000627:therapeutic use*; D000368:Aged; D003000:Clonidine / Q000627:therapeutic use*; D003071:Cognition; D003693:Delirium / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007902:Length of Stay; D008297:Male; D011446:Prospective Studies
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D003000:Clonidine