Royal Surrey County Hospital, Guildford, Surrey, GU2 7XX, UK.
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.
Trials. 2015 Oct 14;16:464. doi: 10.1186/s13063-015-0988-3.
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.
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.
ClinicalTrials.gov NCT02344927 (registered 4 June 2014).
在生命末期提供临床辅助水化是医学中最具争议的问题之一，甚至在普通人群中也是如此。争议的原因包括：a）缺乏证据支持或反对；b）医疗保健专业人员意见分歧；c）患者及其护理人员普遍对临床辅助水化持积极态度。
方法/设计：本研究是一项集群随机试验，旨在评估在生命末期癌症患者中进行充分 powered、随机对照临床试验的可行性。英国 12 个站点，包括 4 家 NHS 医院和 8 家 NHS/志愿部门临终关怀机构，将被随机分配给予标准干预 A：继续口服摄入和定期口腔护理，或标准干预 B：继续口服摄入、定期口腔护理和临床辅助水化。符合以下条件的患者将被纳入研究：i）诊断为癌症；ii）年龄≥18 岁；iii）预计预后≤1 周；iv）无法维持足够的口服摄入（每天 1 升，测量/估计）；v）能够给予知情同意。有临床辅助水化禁忌症的患者将被排除在外。主要研究终点是高活性谵妄（“终末期激越”）的发生频率，这将使用改良 Richmond 激越和镇静量表（每四小时进行一次评估）进行评估。其他收集的数据包括疼痛、呼吸分泌物（“死亡喉音”）、呼吸困难、恶心和呕吐、临床辅助水化的不良反应以及总生存情况的发生频率。此外，还将收集抗精神病药物、镇静药物、镇痛药、抗分泌药物和其他临终药物的使用数据。该研究已获得充分的伦理批准。
迫切需要在生命末期护理中进行临床辅助水化的随机对照试验。这项可行性研究将使我们能够了解和解决方法学和伦理学问题，以确保设计出一项稳健、powered、随机对照试验。
ClinicalTrials.gov NCT02344927（2014 年 6 月 4 日注册）。
