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

Fresenius Kabi

Status and phase: Withdrawn; Phase 4

Conditions: Malnutrition

Treatments: Drug: Kabiven®; Drug: Compounded standard parenteral nutrition

Study type: Interventional

Funder types: Industry

Identifiers

NCT03481894

KABI-004-CP3

Details and patient eligibility

About

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.

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Kabiven®

Experimental group

Description:

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.

Treatment:

Drug: Kabiven®

Compounded standard parenteral nutrition

Active Comparator group

Description:

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".

Treatment:

Drug: Compounded standard parenteral nutrition