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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03481894
• Other study ID #: KABI-004-CP3
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2018
• Est. completion date: March 2021

Study information

• Verified date: September 2019
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Drug:
• Kabiven®
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.
• Compounded standard parenteral nutrition
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.

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

United States, 

Outcome

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