Effectiveness and safety of two lipid emulsions for parenteral nutrition in postsurgical critically ill patients:® Clinoleic® versus SMOFlipid

Abstract

Introduction: a lipid emulsion (LE) may result in different immunomodulatory effects depending on its fatty acid composition. LEs enriched with fish oil and those based on olive oil (OOBE) have shown advantages over those derived from soybean oil, although very few studies have compared these with each other, and none was performed in critically ill surgical patients. Objectives: to demonstrate non-inferiority for the therapeutic efficacy of SMOFlipid® (enriched with fish oil) versus Clinoleic® (OOBE) in relation to the occurrence of nosocomial infection and other evolutionary parameters. To demonstrate non-inferiority in the safety profile of SMOFlipid® versus Clinoleic® in terms of mortality and adverse events. Material and method: a phase-III, non-inferiority clinical trial performed in critically ill postsurgical patients. The subjects were randomized to receive SMOFlipid® or Clinoleic®. For comparison of qualitative variables case frequencies and percentages were obtained using the Chi-squared test or Fisher's exact test. Means were compared between groups using Student's t-test. A p-value lower than 0.05 was considered statistically significant. The Farrington-Manning, Miettinen-Nurminen, and Gart-Nam tests were applied in the main non-inferiority analysis of the primary endpoint. Results: during de inclusion period 73 patients were selected, 37 of whom received Clinoleic® and 36 SMOFlipid®. Regarding the variable "decrease in nosocomial infections", SMOFlipid® proved to be non-inferior to Clinoleic®. Regarding the main variable "mortality", SMOFlipid® proved to be non-inferior to Clinoleic®. There were no statistically significant differences in the occurrence of adverse effects either. Conclusions: in our study, SMOFlipid® proved to be non-inferior to Clinoleic® in terms of efficacy and safety.