Four Parenteral Lipid Emulsions and the Liver Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Liver function
研究概览
简要总结
The randomized, double-blind, multi-centric study performed in four parallel groups to compare all lipid emulsions, which can be used as a part of PN. Patients with home parenteral nutrition due to stable intestinal failure, were randomly assigned to receive parenteral nutrition with one the following lipid emulsions:
- Long-chained triglycerides (LCT group)
- Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))
- Olive oil/ LCT (80:20, OO group))
- SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)
详细描述
Intravenous lipid emulsion (IVLE) is the essential component of parenteral nutrition (PN), because it is a very efficient source of energy and essential fatty acids (FA).The prevalence of abnormal liver function tests during PN varies from 15 to 85%, according to most authors.[19-21] The severity of IFALD depends also on underlying disease, especially ongoing sepsis and pre-existing liver disease. A study comparing all lipid emulsions, which can be used as a part of PN, has never been done. The aim of the study was to compare the clinical value of the four most popular intravenous lipid emulsions in regards to the liver function in long term intestinal failure patients.Patients with home parenteral nutrition due to stable intestinal failure, were randomly assigned to receive parenteral nutrition with one the following lipid emulsions:
- Long-chained triglycerides (LCT group)
- Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))
- Olive oil/ LCT (80:20, OO group))
- SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group) Randomization was performed after assessment and check for in-/exclusion criteria if the patient has met all study eligibility requirements.
The test emulsion became a part of regular PN admixture, which was used to feed patient at home. The study was performed for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
No information on the lipid emulsion's type provided neither to the patient nor the leading physician
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
- •chronic intestinal failure (CIF) receiving HPN including lipids
- •metabolic stability on HPN for more than three months (metabolic stability = the absence of pathological laboratory resulting in the change of PN regime for at least one month)
- •1.0 g lipids/kg body weight per day as a part of PN
排除标准
- •Existing liver failure: an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 1.5 times x normal value
- •Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
- •Patients with history of cancer and anti-cancer treatment within the last 5 years
- •Severe hyperlipidemia
- •Severe coagulopathy
- •Severe renal insufficiency
- •Acute thromboembolic events
- •Positive test for HIV, Hepatitis B or C (from medical history)
- •Known or suspected drug or alcohol abuse
- •Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
- •For women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/ and lactation
研究组 & 干预措施
Provision of LCT emulsions in PN
Intervention: Lipid Emulsions, Intravenous. Daily provision of LCT-based lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
干预措施: Lipid Emulsions, Intravenous (Drug)
Provision of MCT/LCT emulsions in PN
Intervention: Lipid Emulsions, Intravenous. Daily provision of MCT/LCT lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
干预措施: Lipid Emulsions, Intravenous (Drug)
Provision of Olive oil emulsions in PN
Intervention: Lipid Emulsions, Intravenous. Daily provision of Olive-oil/ LCT lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
干预措施: Lipid Emulsions, Intravenous (Drug)
Provision of SMOF lipid emulsions in PN
Intervention: Lipid Emulsions, Intravenous. Daily provision of SMOF lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
干预措施: Lipid Emulsions, Intravenous (Drug)
结局指标
主要结局
Liver function
时间窗: 12 months
Measurement of bilirubin - at the beginning and every three months up to 12 months
次要结局
- Liver function 3(12 months)
- Liver function 4(12 months)
- Liver function 2(12 months)
- Liver function 5(12 months)
研究者
Stanislaw Klek
Head of the Department
Stanley Dudrick's Memorial Hospital