Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Prealbumin
研究概览
简要总结
Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).
详细描述
Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.
There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.
The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older
- •Patients with PN during their hospitalization
- •Patients hospitalized in medical, surgical or ICU wards
- •Signed informed consent either from the patient, their legally authorized representative or a direct family member
排除标准
- •• Patients without PN during their hospitalization
研究组 & 干预措施
Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
干预措施: Intralipid (Drug)
ClinOleic
Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid. ClinOleic is approved by Health Canada. The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.
干预措施: ClinOleic (Drug)
结局指标
主要结局
Prealbumin
时间窗: at day 10
prealbumin is an hepatic protein that is used in the diagnosis of malnutrition. It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.
次要结局
- Length of Stay(participants will be followed for the duration of hospital stay up to one year)
- Mortality(participantes will be followed for the duration of hospital stay for up to 1 year)
- Infections(until one week post-PN up to 1 year)
- Change in Hand-grip Strength(at baseline (day 0) and day 10 of PN)
- Change in Mid-arm Circumference(at baseline (day0) and day 10)
- Subjective Global Assessment (SGA): Number Who Improved(at baseline (day 0) and day 10)
- Change in High Sensitivity C-reactive Protein (Hs-CRP)(Baseline (day 0) and day 10)
- Red Blood Cell Fatty Acid Composition: Linoleic(day 10)
研究者
Johane Allard
Professor of Medicine, Director-Division of Gastroenterology
University Health Network, Toronto