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。在美国媒体和医学文献中，关于生命末期水合作用的争论引起了激烈的争论。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症护理机构接受肠外补水，但几乎从未在临终关怀医院接受。不幸的是，晚期癌症患者在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关注肠外补水的潜在优点和缺点。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，肠外补水可减少晚期癌症患者与脱水相关的症状。本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护理人员生活质量和数量的影响。我们提出了一项随机对照临床试验，以确定肠外水化（1,000 mL生理盐水/天）是否优于安慰剂（100 mL生理盐水）在改善与脱水相关的症状，如疲劳、肌痉挛、镇静、晚期癌症患者接受安宁疗护时的幻觉和谵妄，肠外水合是否在延迟谵妄发作或降低谵妄严重程度方面优于安慰剂，肠外水合是否优于安慰剂延长生存期，以及向家庭主要照护者描述生命末期脱水和再水合的意义。为了实现这些目标，将在研究登记时、治疗期间和治疗结束时对一系列症状进行评估。我们假设接受肠外水合治疗的患者可以减轻症状负担，延迟发作和降低谵妄的严重程度，延长生存期。在这项研究中，我们将测试通过静脉输液是否会改善症状，延缓混乱，延长生命末期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.