A Cluster Randomised Trial of Alternative Forms of Hydration in Cancer Patients in the Last Days of Life (Feasibility Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Recruitment rate
研究概览
简要总结
It is unclear whether the use of fluids given by a "drip" is beneficial to cancer patients in the last days of life, and as a result many individuals do not receive such treatment (although they do receive fluids by mouth, and regular mouth care). The researchers want to undertake a large study ("main study") to determine the benefits of fluids given by a drip, but first need to undertake a small study ("feasibility study") to ensure that the main study can be done.
The feasibility study will be done in twelve units (hospitals, hospices) in England & Wales; each unit will be allocated a treatment at random, and all patients in the unit will receive that treatment (if appropriate). Standard treatment A consists of drinking fluids (if possible), regular mouth care, and treatment of any symptoms; standard treatment B consists of drinking fluids (if possible) , regular mouth care, fluids by a drip, and treatment of any symptoms.
Patients will be assessed on a four hourly basis, and any uncontrolled symptoms will be recorded. The main symptom of interest is agitation ("delirium"), which has multiple causes, including dehydration and kidney failure. Uncontrolled symptoms will be appropriately treated, e.g. patients with pain will be given painkillers. Equally, problems relating to the fluids given by a drip will also be recorded. Involvement in the study will not interfere with the patient's general care, and there will be no additional blood or other tests.
详细描述
Background:
The provision of clinically-assisted hydration (CAH) 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:
- the lack of evidence for / against CAH;
- the disparate opinions of healthcare professionals about CAH;
- the generally positive opinions of patients and their carers about CAH (and the generally negative opinions about withholding / withdrawing CAH).
It is, therefore, unsurprising that the provision of CAH at the end-of-life is extremely variable within clinical practice (i.e. 12-88% cancer patients in the last week of life).
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cancer
- •Age ≥ 18 yr
- •Estimated prognosis of ≤ 1 week
- •Patient unable to maintain sufficient oral intake (1L / day)
排除标准
- •Patient clinically dehydrated
- •Patient has hyperactive delirium ("terminal agitation") at present
- •Patient has had hyperactive delirium ("terminal agitation") in the last 24hr
- •Clinical indication for clinically-assisted hydration (e.g. hypercalcaemia)
- •Clinical contra-indication to clinically-assisted hydration (e.g. cardiac failure)
- •Clinical contra-indication to peripheral cannulation
- •Intravenous fluids / subcutaneous fluids / total parenteral nutrition (TPN) / enteral feeding or fluids already being administered
- •Patient likely to be transferred to another setting for end of life care (e.g. home, hospice)
研究组 & 干预措施
Non-Clinically Assisted Hydration arm
The interventions utilised within this trial are representative of standard clinical practice
- Continuance of oral intake (if appropriate)
- Regular (4 hourly) mouth care
- Standard management of pain and other symptoms in the terminal phase.
干预措施: Non-Clinically Assisted Hydration arm (Other)
Clinically Assisted Hydration arm
The interventions utilised within this trial are representative of standard clinical practice
- Continuance of oral intake (if appropriate)
- Regular (4 hourly) mouth care
- Clinically-assisted hydration
- Standard management of pain and other symptoms in the terminal phase
干预措施: Clinically Assisted Hydration arm (Other)
结局指标
主要结局
Recruitment rate
时间窗: Up to 12 months
Sample size is 200
次要结局
- Retention (% participants complete the study in a one year period)(Up to 12 months)
- Adherence (% nursing observation completed in a one year period)(Up to 12 months)
- Treatment related adverse events(Up to 12 months)