Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- AST
研究概览
简要总结
Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- 否
入选标准
- •Age greater than 18 years
- •current Mayo Clinic HPN patient, able to provide informed consent, anticipated duration of HPN greater than 3 months
- •infusion company is able to provide SMOFlipid
- •no history of alcohol addiction
- •noted to be intolerant to SO based IVFE as defined below.
排除标准
- •Pregnant women
- •failure to provide consent
- •patients who are deemed to be on HPN for less than three months
- •patients who have previous proven addiction and dependence to alcohol/ heavy alcohol consumption reported (during history or reported in the EMR), known hypersensitivity to fish, egg, or soy, patients who will not be managed by the Mayo Clinic HPN team and patients who have active infection (as determined by the clinician) at the time of enrollment.
研究组 & 干预措施
SMOFLipid
Patients in this arm with be randomized to SMOFlipid as their lipid emulsion
干预措施: SMOFLipid (Drug)
Standard therapy
Patients in this arm will be continue with their current lipid emulsion
干预措施: Standard therapy (Drug)
结局指标
主要结局
AST
时间窗: 3-12 months
Primary aim is to assess impact on AST (liver enzyme)
Glucose
时间窗: 3-12 months
blood glucose
Triglycerides
时间窗: 3-12 months
blood triglycerides
ALT
时间窗: 3-12 months
liver enzyme
Total bilirubin
时间窗: 3-12 months
Liver study
CRP
时间窗: 3-12 months
inflammatory marker
次要结局
未报告次要终点
研究者
Manpreet S. Mundi
Assistant Professor
Mayo Clinic