Last updated on May 2019

Efficacy and Safety of SmofKabiven Emulsion for Infusion Versus Hospital Compounded Emulsion "All in One" for Parenteral Nutrition

Brief description of study

The present protocol describes a randomized, patient-blinded study in which either SmofKabiven emulsion for infusion or a hospital compounded "All in one" control Total Parenteral Nutrition (TPN) regimen will be given to adult surgical patients for 5 consecutive days. As serum prealbumin is a well-established surrogate efficacy parameter reflecting the patients nutritional status, the change of the serum prealbumin level at the day of the final study visit compared to baseline will represent the primary efficacy parameter in the present study. In addition, other variables will be assessed in this study, i.e., postsurgical new onset of nosocomial infection, CRP, free fatty acids, immunology parameters, the results of physical examination, vital signs, relevant nutrition- and safety-related laboratory parameters in venous blood and urine, the results of an Electrocardiography (ECG), and the number, severity, seriousness, clinical relevance, relatedness and outcome of Adverse Events (AEs). The aim of the planned study is to demonstrate that SmofKabiven emulsion for infusion is not inferior to the comparative drug (hospital compounded "All in one" emulsion for parenteral nutrition).

Clinical Study Identifier: NCT03792100

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