Prospective, Randomized, Open-Label, Parallel-Group, Active-Controlled, Multicenter Study to Assess Safe and Effective Doses of Kabiven® in Pediatric Patients 2 to 16 Years of Age
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Vital signs: heart rate
研究概览
简要总结
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.
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
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 2 to 16 years of age
- •Patients who require at least 80% of their caloric intake as PN at study start, and in whom an indication for PN is expected for at least 5 days
- •Patients who require a central venous line to receive PN or already have a central venous line in place for other reasons
- •Written informed consent from legal representative(s)
排除标准
- •Known hypersensitivity to egg, soybean proteins, peanut proteins, corn or corn products, or to any of the active substances or excipients
- •Severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration >1,000 g/dL).
- •Inborn errors of amino acid metabolism
- •Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support)
- •Hemophagocytic syndrome.
- •PN in the last 7 days prior to study enrollment.
- •Need for chronic PN before study start
- •Liver enzymes (either AST, ALT, GGPT), or direct bilirubin exceeding 2 x upper limit of normal range
- •Pathologically altered level of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate) unless corrected prior to the start of study treatment
- •Pathologically altered blood pH, or oxygen saturation, or carbon dioxide unless corrected prior to the start of study treatment
- •Pregnancy or lactation
- •Participation in another clinical study
研究组 & 干预措施
Kabiven®
Kabiven is a sterile, hypertonic emulsion in a three chamber container. The separate chambers contain either amino acids with electrolytes, dextrose, or lipid injectable emulsion.
干预措施: Kabiven® (Drug)
Compounded standard parenteral nutrition
The control drug will be compounded for each individual patient as prescribed by the physician. Compounding will be performed according to normal hospital procedure which meets the requirements of the United States Pharmacopeial Convention (USP) <797> "Pharmaceutical Compounding-Sterile Preparations".
干预措施: Compounded standard parenteral nutrition (Drug)
结局指标
主要结局
Vital signs: heart rate
时间窗: Day 1 - 9
Need for mechanical ventilation
时间窗: Days 1-9
Change from baseline body weight on days 5 and 9
时间窗: Days 1, 5, 9
Change from baseline albumin on days 5 and 9
时间窗: Days 1, 5, 9
Change from baseline prealbumin on days 5 and 9
时间窗: Days 1, 5, 9
Change from baseline transferrin on days 5 and 9
时间窗: Days 1, 5, 9
Change from baseline direct bilirubin on days 2, 5 and 9 on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Duration of renal replacement therapy
时间窗: Days 1-9
All adverse events (AE)
时间窗: After randomization until Day 9
Vital signs: blood pressure
时间窗: Day 1 - 9
Vital signs: body temperature
时间窗: Day 1 - 9
Change from baseline alanine aminotransferase (ALT) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Vital signs: saturation of peripheral oxygen (spO2)
时间窗: Days 1-9
Change from baseline urea nitrogen on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline aspartate aminotransferase (AST) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Urine volume
时间窗: Days 1-9
Vital signs: respiratory rate
时间窗: Day 1 - 9
Change from baseline total bilirubin on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline gamma-glutamyl transpeptidase (GGTP) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline alkaline phosphatase (ALP) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline creatinine on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline electrolytes (sodium, potassium, magnesium, calcium, chloride, phosphate) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline osmolarity on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline pH on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline glucose on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline cholesterol on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline amylase on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline total protein on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline triglycerides on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline lipase on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline c-reactive protein (CRP) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline white blood cells (WBC) count on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline platelet count on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline red blood cells (RBC) count on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline hemoglobin (hgb) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline Hematocrit (hct) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline international normalized ratio (INR) on days 2, 5 and 9
时间窗: Days 1, 2 (or if not done: Day 3), 5, 9
Need for renal replacement therapy
时间窗: Days 1-9
Nosocomial infection
时间窗: After randomization until Day 9
Number of health care associated infections
Duration of mechanical ventilation
时间窗: Days 1-9
Change from baseline alpha linolenic acid on days 5 and 9
时间窗: Days 1, 5, 9
Change from baseline linoleic acid on days 5 and 9
时间窗: Days 1, 5, 9
Change from baseline arachidonic acid on days 5 and 9
时间窗: Days 1, 5, 9
Change from baseline eicosatrienoic (mead) acid on days 5 and 9
时间窗: Days 1, 5, 9
Change from baseline triene/tetraene ratio (Holman index) on days 5 and 9
时间窗: Days 1, 5, 9
次要结局
未报告次要终点