Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Malnutrition

Intervention / Treatment
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* Drug: Kabiven®
* Drug: Compounded standard parenteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kabiven®<br>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. | Drug: Kabiven®<br>* Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories. The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours. Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy.<br>* Other names: Kabiven® for intravenous use (investigational drug);|
| Active Comparator: Compounded standard parenteral nutrition<br>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. | Drug: Compounded standard parenteral nutrition<br>* Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories. The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours. Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy.<br>* Other names: Compounded standard parenteral nutrition (control drug);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events (AE) |  | After randomization until Day 9 | 
| Vital signs: blood pressure |  | Day 1 - 9 | 
| Vital signs: heart rate |  | Day 1 - 9 | 
| Vital signs: body temperature |  | Day 1 - 9 | 
| Vital signs: respiratory rate |  | Day 1 - 9 | 
| Vital signs: saturation of peripheral oxygen (spO2) |  | Days 1-9 | 
| Urine volume |  | Days 1-9 | 
| Change from baseline urea nitrogen on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline alanine aminotransferase (ALT) on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline aspartate aminotransferase (AST) on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline direct bilirubin on days 2, 5 and 9 on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline total bilirubin on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline gamma-glutamyl transpeptidase (GGTP) on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline alkaline phosphatase (ALP) on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline creatinine on days 2, 5 and 9 |  | 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 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline osmolarity on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline pH on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline glucose on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline triglycerides on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline cholesterol on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline lipase on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline amylase on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline total protein on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline c-reactive protein (CRP) on days 2, 5 and 9 |  | 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 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline platelet count on days 2, 5 and 9 |  | 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 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline hemoglobin (hgb) on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline Hematocrit (hct) on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Change from baseline international normalized ratio (INR) on days 2, 5 and 9 |  | Days 1, 2 (or if not done: Day 3), 5, 9 | 
| Nosocomial infection | Number of health care associated infections | After randomization until Day 9 | 
| Need for renal replacement therapy |  | Days 1-9 | 
| Duration of renal replacement therapy |  | Days 1-9 | 
| Need for mechanical ventilation |  | Days 1-9 | 
| Duration of mechanical ventilation |  | Days 1-9 | 
| Change from baseline body weight on days 5 and 9 |  | Days 1, 5, 9 | 
| Change from baseline albumin on days 5 and 9 |  | Days 1, 5, 9 | 
| Change from baseline prealbumin on days 5 and 9 |  | Days 1, 5, 9 | 
| Change from baseline transferrin on days 5 and 9 |  | Days 1, 5, 9 | 
| Change from baseline alpha linolenic acid on days 5 and 9 |  | Days 1, 5, 9 | 
| Change from baseline linoleic acid on days 5 and 9 |  | Days 1, 5, 9 | 
| Change from baseline arachidonic acid on days 5 and 9 |  | Days 1, 5, 9 | 
| Change from baseline eicosatrienoic (mead) acid on days 5 and 9 |  | Days 1, 5, 9 | 
| Change from baseline triene/tetraene ratio (Holman index) on days 5 and 9 |  | Days 1, 5, 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenteral nutrition, Malnutrition, Pediatrics, nutritional needs