NCT05257031

Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care

An Open-label, Non-Comparative, Multicentre Trial to Assess the Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to assess the efficacy and safety of the investigational product SmofKabiven extra Nitrogen in patients requiring parenteral nutrition (PN) to achieve the target protein dose. The cumulative target protein dose is 6.2 g per kg of body weight (BW) over the five study treatment days, with 1.0 g/kg BW on Study Day 1 and 1.3 g/kg BW per day on Study Days 2-5; the target caloric intake is 15 kcal/kg BW on Study Day 1 and 20 kcal/kg BW/day on Study Days 2-5, following the recommendation of the ESPEN guideline on clinical nutrition in the intensive care unit 2019 regarding a slow-ramp up of calories during the first week of critical illness.

Conditions

• Nutrition Therapy
• Critical Illness

Interventions

Type	Name	Description
DRUG	SmofKabiven extra Nitrogen	SmofKabiven extra Nitrogen contains amino acids (Aminoven®), glucose, lipids (SMOFlipid®: 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, 15% fish oil), and electrolytes.

Timeline

• Start date: 2022-02-12
• Primary completion: 2022-09-11
• Completion: 2023-06-30
• First posted: 2022-02-25
• Last updated: 2024-02-21

Locations

1 site across 1 country: Russia