Clinical trial NCT03481894: Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Malnutrition
Keywords: Parenteral nutrition
Malnutrition
Pediatrics
nutritional needs
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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

Primary outcomes:
measure: All adverse events (AE)
timeFrame: After randomization until Day 9
measure: Vital signs: blood pressure
timeFrame: Day 1 - 9
measure: Vital signs: heart rate
timeFrame: Day 1 - 9
measure: Vital signs: body temperature
timeFrame: Day 1 - 9
measure: Vital signs: respiratory rate
timeFrame: Day 1 - 9
measure: Vital signs: saturation of peripheral oxygen (spO2)
timeFrame: Days 1-9
measure: Urine volume
timeFrame: Days 1-9
measure: Change from baseline urea nitrogen on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline alanine aminotransferase (ALT) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline aspartate aminotransferase (AST) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline direct bilirubin on days 2, 5 and 9 on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline total bilirubin on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline gamma-glutamyl transpeptidase (GGTP) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline alkaline phosphatase (ALP) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline creatinine on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline electrolytes (sodium, potassium, magnesium, calcium, chloride, phosphate) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline osmolarity on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline pH on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline glucose on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline triglycerides on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline cholesterol on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline lipase on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline amylase on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline total protein on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline c-reactive protein (CRP) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline white blood cells (WBC) count on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline platelet count on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline red blood cells (RBC) count on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline hemoglobin (hgb) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline Hematocrit (hct) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Change from baseline international normalized ratio (INR) on days 2, 5 and 9
timeFrame: Days 1, 2 (or if not done: Day 3), 5, 9
measure: Nosocomial infection
timeFrame: After randomization until Day 9
measure: Need for renal replacement therapy
timeFrame: Days 1-9
measure: Duration of renal replacement therapy
timeFrame: Days 1-9
measure: Need for mechanical ventilation
timeFrame: Days 1-9
measure: Duration of mechanical ventilation
timeFrame: Days 1-9
measure: Change from baseline body weight on days 5 and 9
timeFrame: Days 1, 5, 9
measure: Change from baseline albumin on days 5 and 9
timeFrame: Days 1, 5, 9
measure: Change from baseline prealbumin on days 5 and 9
timeFrame: Days 1, 5, 9
measure: Change from baseline transferrin on days 5 and 9
timeFrame: Days 1, 5, 9
measure: Change from baseline alpha linolenic acid on days 5 and 9
timeFrame: Days 1, 5, 9
measure: Change from baseline linoleic acid on days 5 and 9
timeFrame: Days 1, 5, 9
measure: Change from baseline arachidonic acid on days 5 and 9
timeFrame: Days 1, 5, 9
measure: Change from baseline eicosatrienoic (mead) acid on days 5 and 9
timeFrame: Days 1, 5, 9
measure: Change from baseline triene/tetraene ratio (Holman index) on days 5 and 9
timeFrame: Days 1, 5, 9
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital, Kansas City, MO 64108
name: Joel D Lim, MD
role: PRINCIPAL_INVESTIGATOR
References: