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临床试验/NCT02539316
NCT02539316已完成4 期

Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
9
试验地点
1
主要终点
dosage of γGT in UI/l

研究概览

简要总结

Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially in premature infants. It results in an increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied in the adult population and in the preterm in the PN on short and long, with the finding of a hepatoprotection. Investigators do not find a single retrospective study about it in Pediatric Onco-Hematology. No prospective studies have been performed in the population of Onco-Hematology. The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.

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
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 0-18 years
  • Solid Tumors
  • hematological malignancies
  • Requiring parenteral nutrition during at least 5 days
  • With a central catheter
  • With a normal hepatic function test

排除标准

  • Liver function tests disrupted
  • Patient with a tumor or liver metastases
  • Patient with against-indication to the use of lipid

研究组 & 干预措施

Médialipides

Active Comparator

parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC)

干预措施: Médialipides (Drug)

SmofLIPID

Experimental

parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC)

干预措施: Smoflipid (Drug)

结局指标

主要结局

dosage of γGT in UI/l

时间窗: 7 days after the end of parenteral nutrition

次要结局

  • Infectious episodes (numbers, duration)(7 days after the end of parenteral nutrition)
  • asat, alat, PAL, LDH, total bilirubin CRP(7 days after the end of parenteral nutrition)
  • Nutritionnal status(7 days after the end of parenteral nutrition)
  • Triglycerids Digestive tolerance (vomiting)(7 days after the end of parenteral nutrition)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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