title: Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The provision of clinically assisted hydration at the end of life is one of the most contentious issues in medicine, and indeed within the general population. The reasons for contention include: a) the lack of evidence for or against; b) the disparate opinions of healthcare professionals; and c) the generally positive opinions of patients and their carers about clinically assisted hydration.
  
  
  METHODS
  The study is a cluster randomised trial to assess the feasibility of conducting an adequately powered, randomised controlled trial of clinically assisted hydration in patients with cancer in the last days of life. Twelve sites, four National Health Service (NHS) hospitals and eight NHS/voluntary sector hospices in the United Kingdom, will be randomised to give either standard intervention A: continuance of oral intake and regular mouth care, or standard intervention B: continuance of oral intake, regular mouth care and clinically assisted hydration. Patients will be included if they: i) have a diagnosis of cancer; ii) are aged ≥ 18 yr; iii) have an estimated prognosis of ≤ 1 week and iv) are unable to maintain sufficient oral intake (1 L per day, measured/estimated); and v) are able to give informed consent. Patients will be excluded if they have contra-indications to receiving clinically assisted hydration. The primary endpoint of interest is the frequency of hyperactive delirium ('terminal agitation'), and this will be assessed using the Modified Richmond Agitation and Sedation Scale (administered every four hours). Other data to be collected include the frequency of pain, respiratory secretions ('death rattle'), dyspnoea, nausea and vomiting, adverse effects to clinically assisted hydration and overall survival. In addition, data will be collected on the use of anti-psychotic drugs, sedative drugs, analgesics, anti-secretory drugs and other end-of-life medication. The study has obtained full ethical approval.
  
  
  CONCLUSIONS
  A randomised controlled trial of clinically assisted hydration in end-of-life care is urgently required. This feasibility study will allow methodological and ethical issues to be understood and addressed to ensure that a robust, adequately powered, randomised controlled trial is designed.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02344927 (registered 4 June 2014).
authors.affiliation: Royal Surrey County Hospital, Guildford, Surrey, GU2 7XX, UK. adavies12@nhs.net.
authors.forename: Andrew
authors.initials: A
authors.lastname: Davies
authors.affiliation: Royal Surrey County Hospital, Guildford, Surrey, GU2 7XX, UK. melaniewaghorn@nhs.net.
authors.forename: Melanie
authors.initials: M
authors.lastname: Waghorn
authors.affiliation: Surrey CTU, Surrey Clinical Research Centre, School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Egerton Road, Guildford, Surrey, GU2 7XH, UK. j.boyle@surrey.ac.uk.
authors.forename: Julia
authors.initials: J
authors.lastname: Boyle
authors.affiliation: School of Health Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, GU2 5XH, UK. A.Gallagher@surrey.ac.uk.
authors.forename: Ann
authors.initials: A
authors.lastname: Gallagher
authors.affiliation: Surrey CTU, Surrey Clinical Research Centre, School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Egerton Road, Guildford, Surrey, GU2 7XH, UK. S.Johnsen@surrey.ac.uk.
authors.forename: Sigurd
authors.initials: S
authors.lastname: Johnsen
mesh_terms: D002985:Clinical Protocols; D003693:Delirium / Q000209:etiology / Q000517:prevention & control; D005240:Feasibility Studies; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods*; D006304:Health Status; D006801:Humans; D009369:Neoplasms / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D009910:Oral Hygiene; D010166:Palliative Care / Q000379:methods*; D019338:Polypharmacy; D012107:Research Design; D013727:Terminal Care / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014882:Water-Electrolyte Balance