Prophylactic Early PN in HPT/BMT
Prophylactic Early Parenteral Nutrition in Patients Undergoing Hematopoietic Cell Transplantation: A Multi-centre Randomised Controlled Trial.
研究概览
详细说明
A standard parenteral nutrition solution will be used. The parenteral nutrition solution will be given once daily, and infused intravenously. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L). Nutritional targets will be measured using indirect Calorimetry where available, or calculated via the Harris Benedict or Schofield equations. The dose of parenteral nutrition administered will be determined by the treating dietitian, treating physician or treating research team. The parenteral nutrition dose given will be individualised considering the patients clinical condition and body weight. The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake.
Supplemental parenteral nutrition will be discontinued when a patient is well enough to be discharged from hospital or when the patients attending clinician determines a central line is no longer needed for standard care. There is no maximum duration of supplemental parenteral nutrition..
Adherence to the study intervention will be monitored via medical chart reviews during site monitoring visits, and data queries on individual patient case report form documentation.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Gordon S Doig, PhD
- 电话号码:+61294632600
- 邮箱:gdoig@med.usyd.edu.au
研究联系人备份
- 姓名:Fiona Simpson, PhD
- 电话号码:+61294632600
- 邮箱:fsimpson@med.usyd.edu.au
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients who are about to commence conditioning chemoradiotherapy for allogeneic haematopoietic progenitor/stem cell transplantation, who have a haematological malignancy, who are not meeting 80% of their Caloric needs via oral or enteral intakes, and who are not malnourished.
Exclusion Criteria:
- Patients who are already receiving parenteral nutrition at time of screening.
- Patients with a documented licensing contraindication to parenteral nutrition.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Standard Care
The control group in this study is pragmatic standard nutrition care.
Currently after a bone marrow transplant in Australia, patients are normally fed orally for as long as possible.
If oral intake fails to provide sufficient calories for a period of two to three days, enteral or parenteral nutrition may be provided.
|
Nutrition support will be provided as per usual care.
|
有源比较器:Early supplemental parenteral nutrition
Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell transplant. The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake. |
Nutrition support will be provided as per usual care.
Nutrition support will be provides as per usual, but oral and enteral intake will be topped up with a standard parenteral nutrition solution.
The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L).
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Disease free survival time
大体时间:Recruitment will run for 3 years, with a median follow-up time of 2 years.
|
Defined as time to relapse or death whichever occurs first
|
Recruitment will run for 3 years, with a median follow-up time of 2 years.
|
合作者和调查者
合作者
调查人员
- 首席研究员:Gordon S Doig, PhD、Northern Clinical School Intensive Care Research Unit, University of Sydney
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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