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FDA released Fresenius Kabi from this post marketing requirement on 07/16/2019.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kabiven® | Experimental | 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. |
|
| Compounded standard parenteral nutrition | Active Comparator | 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". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kabiven® | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel D Lim, MD | Children's Mercy Hospital, Kansas City, MO 64108 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States | ||
| Children's Mercy Hospital |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015507 | Drugs, Investigational |
| D004335 | Drug and Narcotic Control |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D007880 | Legislation, Drug |
| D007878 | Legislation as Topic |
| D012926 | Social Control, Formal |
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|
|
| Compounded standard parenteral nutrition | Drug | 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. |
|
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| 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 |
| Kansas City |
| Missouri |
| 64108 |
| United States |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004472 | Health Care Economics and Organizations |
| D010605 | Pharmacy Administration |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |