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Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial

Davies, A, Waghorn, M, Boyle, J, Gallagher, MA and Johnsen, S (2015) Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial Trials, 16. pp. 464-472.

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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/design 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. Discussion 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.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences
Authors :
AuthorsEmailORCID
Davies, AUNSPECIFIEDUNSPECIFIED
Waghorn, MUNSPECIFIEDUNSPECIFIED
Boyle, JUNSPECIFIEDUNSPECIFIED
Gallagher, MAUNSPECIFIEDUNSPECIFIED
Johnsen, SUNSPECIFIEDUNSPECIFIED
Date : 14 October 2015
Identification Number : 10.1186/s13063-015-0988-3
Uncontrolled Keywords : End-of-life care, Clinically assisted hydration, Palliative care
Additional Information : © 2015 Davies et al. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.
Depositing User : Symplectic Elements
Date Deposited : 17 Nov 2015 10:29
Last Modified : 17 Nov 2015 10:29
URI: http://epubs.surrey.ac.uk/id/eprint/809139

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