Overview
Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age
Status:
Withdrawn
Withdrawn
Trial end date:
2021-03-01
2021-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Fresenius Kabi
Criteria
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