Parenteral Hydration in Advanced Cancer Patients: A Randomized Controlled Trial

描述(申请人提供)：大多数癌症患者死前口服摄入量减少。脱水可引起或加重疲劳、肌阵挛、镇静、幻觉和精神错乱等症状。关于临终时补充水分的影响的争论在美国媒体和医学文献中引起了激烈的辩论。在美国，脱水或口服摄入量减少的晚期癌症患者几乎总是在急性护理机构接受肠外水化治疗，但几乎从未在临终关怀机构接受过。不幸的是，晚期癌症患者在生命末期给予或不给予液体的决定是复杂的，因为几乎完全没有关注肠外水化的潜在优点和缺点的随机对照试验。我们小组进行的唯一一项随机、双盲对照研究表明，与安慰剂相比，肠外水化疗法减少了晚期癌症患者与脱水相关的症状。我们这项研究的长期目标是了解肠外水化对晚期癌症患者及其主要照顾者生活质量和数量的影响。我们提出了这项随机对照临床试验，以确定在接受临终关怀的晚期癌症患者中，肠外水化(每天1000毫升生理盐水)在改善脱水相关症状方面是否优于安慰剂(100毫升生理盐水)，如疲倦、肌阵挛、镇静、幻觉和精神错乱，肠外水化是否优于安慰剂，肠外水化是否优于安慰剂以延长生存期，以及描述脱水和生命末期再水化对家庭主要照顾者的意义。为了实现这些目标，将在研究注册时、治疗期间和治疗结束时测量一系列症状评估。我们假设，接受肠外水化治疗的患者将表现出症状负担减轻，起病延迟，严重程度减轻，生存时间延长。在这项研究中，我们将测试通过静脉输液是否会改善临终患者的症状、推迟困惑和延长生命。

DESCRIPTION (provided by applicant): The majority of cancer patients develop decreased oral intake before death. Dehydration can cause or aggravate symptoms such as fatigue, myoclonus, sedation, hallucinations and delirium. The controversy regarding the effects of hydration at the end of life has resulted in heated debate in American media and in medical literature. In the United States, patients with advanced cancer who have dehydration or decreased oral intake nearly always receive parenteral hydration in acute care facilities but almost never in hospices. Unfortunately, the decision of giving or not giving fluid in advanced cancer patients at the end of life is complicated by nearly complete absence of randomized controlled trials focusing on the potential advantages and disadvantages of parenteral hydration. The only randomized, double blind controlled study conducted by our group suggested that parenteral hydration decreased symptoms associated with dehydration in terminally ill cancer patients as compared with placebo. Our long -term goal of this study is to understand the effect of parenteral hydration on the quality and quantity of life in terminally ill cancer patients and their primary caregivers We propose this randomized, controlled clinical trial to determine whether parenteral hydration (1,000 mL normal saline/day) is superior to placebo (100 ml normal saline) in improving symptoms associated with dehydration such as fatigue, myoclonus, sedation, hallucinations and delirium in patients with advanced cancer receiving hospice care, whether parenteral hydration is superior to placebo in delaying the onset or decreased severity of delirium, whether parenteral hydration is superior to placebo in prolonging survival and to describe the meaning of dehydration and re-hydration at the end of life to family primary caregivers. In order to achieve these goals, a battery of symptom assessments will be mesured at study resgistration, during treatment and at the end of the treatment. We hypothesize that patients receiving parenteral hydration will demonstrate reduced symptom burden, delayed onset and reduced severity of delirium, and prolonged survival. In this study, we will test if giving fluid through the vein will improve the symptoms, delay confusion and prolong life in patients who are no longer to drink at the end of life.