Parenteral Hydration in Advanced Cancer Patients: A Randomized Controlled Trial

描述（由申请人提供）：大多数癌症患者在死亡前口服摄入量减少。脱水可引起或加重疲劳、肌阵挛、镇静、幻觉和谵妄等症状。关于生命末期水合作用的争议在美国媒体和医学文献中引起了激烈的争论。在美国，患有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合作用，但几乎从未在临终关怀机构接受过。不幸的是，在晚期癌症患者生命结束时给予或不给予液体的决定是复杂的，因为几乎完全没有随机对照试验，重点是胃肠外水合作用的潜在优点和缺点。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，肠外补液可减少晚期癌症患者脱水相关的症状。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。我们提出这项随机对照临床试验，以确定肠外水化是否（1，000 mL生理盐水/天）优于安慰剂（上级）（100 ml生理盐水）改善接受临终关怀的晚期癌症患者的脱水相关症状，如疲劳、肌阵挛、镇静、幻觉和谵妄，胃肠外水合作用在延迟谵妄发作或降低谵妄严重程度方面是否上级安慰剂，胃肠外水合作用在延长生存期方面是否上级安慰剂，并向家庭主要护理人员描述生命末期脱水和再水合作用的意义。为了实现这些目标，将在研究重新登记时、治疗期间和治疗结束时测量一系列症状评估。我们假设接受肠外补液的患者将表现出症状负担减轻，谵妄发作延迟和严重程度降低，生存期延长。在这项研究中，我们将测试通过静脉给予液体是否会改善症状，延迟混乱并延长生命结束时不再饮酒的患者的生命。

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.