Intravenous Lipid Emulsions and Liver Function in Adult Chronic Intestinal Failure Patients: New Results After 5 Years.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Liver disfunction
研究概览
简要总结
Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but also one of the key risk factors for development of intestinal failure associated liver disease (IFALD). The aim of the study was to analyse the influence of ILEs on liver function during long term PN.
详细描述
Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but also one of the key risk factors for development of intestinal failure associated liver disease (IFALD). Despite of many commercially available ILEs with hypothetically different impact on liver, a direct comparison of them has never been performed. Therefore the aim of the study was to analyse the influence of ILEs on liver function during long term PN. Ths study is a continuation of the previous trial, NCT03044639.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age,
- •chronic intestinal failure on PN including lipids,
- •metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)
- •ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN
排除标准
- •preexisting liver dysfunction (an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 3 times x normal value),
- •patients with a 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
PN with Olive oil
Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group)
干预措施: Intravenous Lipid Emulsion (Drug)
PN with MCT/LCT
Parenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group)
干预措施: Intravenous Lipid Emulsion (Drug)
PN with SMOFLipid
Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group)
干预措施: Intravenous Lipid Emulsion (Drug)
结局指标
主要结局
Liver disfunction
时间窗: 5 years
Liver tests results during parenteral nutrition
次要结局
未报告次要终点
研究者
Stanislaw Klek
Head of the General Surgery Unit
Stanley Dudrick's Memorial Hospital