Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 5
- 主要终点
- Participant Reduced Symptom Burden
研究概览
简要总结
The goal of this clinical research study is to learn whether being hydrated (given liquids) through a catheter in a vein or in the tissue under the skin can improve symptoms of dehydration.
Objectives:
1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in advanced cancer patients receiving hospice care.
1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or reducing the severity of delirium in patients with advanced cancer receiving hospice care.
1.3 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patient's lives.
详细描述
For Caregivers:
Symptoms of dehydration may include fatigue, muscle contractions, the need for sedation (calming medication), and hallucinations (where something is sensed that is not actually there). Hydration allows the body to get rid of the waste products from medications and other chemicals. When the fluid levels in the body are increased, the brain function may directly improve.
If the patient under your care is found to be eligible to take part in this study, he or she will be randomly assigned (as in the toss of the coin) to one of 2 groups. Participants in Group 1 will receive normal saline (salt water) once a day. Participants in Group 2 will receive a lower amount of normal saline once a day. This lower amount is small enough to be considered a placebo. Doctors call something a placebo if it looks like the substance being tested but has no active ingredients (or in this case, few active ingredients).
Both you and the patient will be asked to complete a number of questionnaires at the beginning of the study, on Days 1-7, and then every 3-5 days after that. Your questionnaires will ask about the feelings you may have about hydration and the care that you are providing to the patient. Each day's questionnaires will take about 30 minutes.
Both you and the patient will also be interviewed by researchers at the beginning of the study and on Day 4 (+/- 2 days). The interviews will include questions about what it has been like for the patient to get fluids, whether the fluid was more like food or medicine, whether the patient has ever gotten dehydrated, and how you manage the patient's care. The interviews should each take about 30 minutes. The interviews in this study will be audio taped so the information can be studied by researchers. Only the research staff will listen to the audio tape of the interviews.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with advanced cancer (local recurrence or metastatic disease) admitted to hospice care
- •Patients have reduced oral intake of fluids, as determined by clinical assessment.
- •Patients exhibit evidence of mild or moderate dehydration as defined by decreased skin turgor in subclavicular region (more than 2 seconds), plus a score of >/= 2/5 in the clinical dehydration assessment
- •In addition to fatigue, (expected to be present in all patients based on our pilot study), patients must score >/= 1 on a 0 to 10 scale (0=no symptom, 10= the worst possible symptom) of two of the three other target symptoms (hallucinations, sedation, and myoclonus) scored
- •Patients are 18 years of age or older
- •Patients have life expectancy of >/= 1 week as determined by their treating physicians
- •Patients who score < 13 (normal range) in the Memorial Delirium Assessment Scale (MDAS) and are able to give written informed consent
- •Patients must be able to tolerate the parenteral treatment application device (butterfly cannula or intravenous access)
- •Patients must have a primary caregiver
- •Patients must reside within 60 miles of M. D. Anderson Cancer Center. Exception to this is for patients referred from Odyssey Health Care of Conroe, patients referred from this site must reside within 75 miles of M.D. Anderson Cancer Center.
- •Inclusion criteria of family caregivers: The family caregiver is a person who is patient's spouse, parent, sibling. child or significant other
- •The family caregiver must reside with the patient and is responsible for the care of the patient. Exception to this is for patients who are admitted to In Patient hospice or nursing homes/rehabilitation centers and are under the care of the hospice.
- •The family caregiver must be 18 years of age or older
- •The family caregiver must be willing to be interviewed by the research nurse and sign written informed consent
排除标准
- •Patient's refuse to participate in the study or are not competent to give informed consent
- •Patients are suffering from severe dehydration defined as decreased blood pressure or low perfusion of limbs, decreased level of consciousness, or no urine output for 12 hours
- •Patients with history or clinical evidence of renal failure. Creatinine >1.5 x *Upper Limit of Normal. (M.D. Anderson Cr ULN=1.5 mg/dl). Therefore, a patient with Creatinine of (CR)> 2.25 mg/dl will be excluded.
- •Patients with history or clinical evidence of congestive heart failure
- •Patients who are not able to complete the baseline assessment forms
- •Patients have history of bleeding disorders demonstrated by clinical evidence of active bleeding, hematuria, hematoma, ecchymoses, and petechiae
- •Patients with brain metastasis, leptomeningeal disease or primary brain tumors will be eligible for participation in this study as long as there is no evidence of altered mental status as demonstrated by a normal score on the Memorial Delirium Assessment Scale (MDAS).
- •The family caregiver refuses to participate in the study
- •The family caregiver has difficulty understanding the intent of the study
研究组 & 干预措施
Hydration: Normal Saline (salt water)
Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily
干预措施: Saline (Drug)
Placebo: Lower Saline
Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
干预措施: Saline (Drug)
结局指标
主要结局
Participant Reduced Symptom Burden
时间窗: From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)
Symptom burden, assessed using the Edmonton Symptom assessment scale, which has been validated in the cancer population. Participants are asked to rate the severity of their symptoms over the previous 24 hours using a numerical rating scale of 0-10, with 0 meaning that the symptom is absent and 10 meaning the worst possible symptom. The mean is a composite outcome where change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations) between day 4 and baseline ranged from 0-40 daily. The reported value was the mean of average change in patients' scores per group.
次要结局
- Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7(Baseline to Day 7)
- Change in Dehydration as Measured by Dehydration Assessment Scale(Baseline to Day 7)
- Reduced Symptom Burden as Measured by RASS, MDAS and UMRS(Baseline to Day 7)
- Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)(Baseline to Day 7 (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))