NCT03481894 - Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Malnutrition

Interventions

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.

Compounded standard parenteral nutritionDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (2)

The University of Chicago Medical Center

Chicago, Illinois, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

All adverse events (AE)

Time frame: After randomization until Day 9

Vital signs: blood pressure

Time frame: Day 1 - 9

Vital signs: heart rate

Time frame: Day 1 - 9

Vital signs: body temperature

Time frame: Day 1 - 9

Vital signs: respiratory rate

Time frame: Day 1 - 9

Vital signs: saturation of peripheral oxygen (spO2)

Time frame: Days 1-9

Urine volume

Time frame: Days 1-9

Change from baseline urea nitrogen on days 2, 5 and 9