Omegaven® as Parenteral Nutrition
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Primary Outcomes/Endpoints ( time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN)
研究概览
简要总结
The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.
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
- 14 Days 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 14 days old.
- •Have PN-associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.
- •Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least 4 more weeks.
- •Patients must have failed standard therapies for Parenteral Nutrition Associated Liver Disease (PNALD) including: cycling of PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and use of ursodiol (i.e. Actigall).
- •Signed patient informed consent.
- •The patient is expected to have a reasonable possibility of survival.
- •No other known etiology of cholestasis other than PNALD at time of Omegaven® initiation.
排除标准
- •Causes of cholestasis other than PNALD including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency, prior to Omegaven® initiation.
- •Known fish or egg allergy
- •Any of the contraindications to use of Omegaven®:
- •Active new infection at the time of initiation of Omegaven®
- •Hemodynamic instability
- •Use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (NSAIDs)
- •Active coagulopathy or bleeding
- •Thrombocytopenia
- •Unstable hyperglycemia
- •Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid
- •History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
- •Unstable diabetes mellitus
- •Collapse and shock
- •Stroke/ Embolism
- •Cardiac infarction within the last 3 months
- •Undefined coma status
- •Enrollment in a clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- •The parent or guardian of child is unwilling to provide consent or assent
研究组 & 干预措施
Omegaven
干预措施: Omegaven (Drug)
结局指标
主要结局
Primary Outcomes/Endpoints ( time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN)
时间窗: Until weaned from PN
Primary efficacy analysis will include time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN).
次要结局
- Growth (weight three times per week, length once weekly, and head circumference)(Until weaned from PN)
- Essential Fatty Acids (evidence of essential fatty acid (EFA) deficiency)(Until weaned from PN)