Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Direct/Indirect Bilirubin Change is assessed
研究概览
简要总结
This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.
详细描述
Primary aim is to assess the impact to direct/indirect bilirubin.
Secondary aims will be to assess impact to other liver function studies, metabolic parameters, inflammatory marker, body weight, ability to meet caloric needs through TPN, and ability to obtain appropriate macronutrient composition.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The randomization list will be generated using http://www.randomization.com and blinded at enrollment using supplement codes. The study coordinator will hold the randomization codes and will be revealed to the investigators only after the statistical analysis is complete.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly initiated Mayo Clinic HPN patient
- •Able to provide informed consent
- •Anticipated duration of HPN greater than 3 months,
- •Infusion company is able to provide Smoflipid
排除标准
- •Age less than 18 years
- •Pregnant and lactating women
- •Failure to provide consent
- •Patients with underlying liver dysfunction (defined as liver function studies equal to or more than 2 times upper limit of normal) or pathology as determined by primary investigator
- •Patients with active malignancy
- •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 AND consumption/active use reported during last 12 months.
- •Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients in Smoflipid
- •Patients who will not be managed by the Mayo Clinic HPN team
- •Patients who have active infection (as determined by the clinician) at the time of enrollment.
- •Patients who have received Smoflipid greater than 4 weeks in the last 12 months prior to enrollment.
- •Patients who have been on TPN greater than 4 weeks in the last 12 months prior to enrollment.
- •Enrolled in another interventional study.
- •Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides more than 1,000 mg/dL.
结局指标
主要结局
Direct/Indirect Bilirubin Change is assessed
时间窗: At 12 weeks weeks
mg/dL
次要结局
未报告次要终点
研究者
Manpreet S. Mundi
Principal Investigator
Mayo Clinic