Compassionate Use of Omegaven IV Fat Emulsion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Level of Bilirubin
研究概览
简要总结
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).
详细描述
Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. However, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to PN associated liver disease.
It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of PN-associated cholestasis may be prevented or reversed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition)
- •Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
- •The patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily PN, trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®).
排除标准
- •Documented causes of chronic liver disease other than parenteral nutrition associated liver disease
- •Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
- •An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven®
- •Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
- •Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
- •Unstable diabetes mellitus or hyperglycemia
- •Stroke, embolism, collapse and shock, recent MI
- •Cholestasis due to any reason other than parenteral associated liver disease
- •Active new infection at time of initiation of Omegaven®
- •Hemodynamic instability
- •The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).
研究组 & 干预措施
Omegaven
All subjects will receive Omegaven
干预措施: Omegaven (Drug)
结局指标
主要结局
Level of Bilirubin
时间窗: week 2, 3,4,and 8
measurement of bilirubin level weekly. Available data reported.
次要结局
未报告次要终点
研究者
Cindy Haller
Physician
Northwell Health