Evaluation of the stability and safety of Venolipid MCT/LCT 20% administered by an all-in-one system in patients after major gastrointestinal surgery

Background & aims: A structured fat emulsion containing 50% medium-chain triglycerides (MCTs) is used for total parenteral nutrition for surgical patients. Due to stability and safety considerations, it is commonly infused separately from dextrose solution, increasing cost and risk of contamination. We evaluated the physiochemical stability and clinical safety of an all-in-one admixture. Methods: The physiochemical stability of an all-in-one admixture containing 20% medium- and long-chain triglycerides (Venolipid MCT/LCT 20%), dextrose, amino acids, electrolytes, trace elements and vitamins was compared to a two-in-one system. Solutions were stored at 4 °C for 1 week; appearance, pH, osmolality and particle size and distribution were analyzed at room temperature on days 1, 4 and 7. Clinical safety of the all-in-one admixture versus use of separate systems was determined in patients after major upper abdominal surgery in a prospective, randomized, controlled study (total n = 30). Results: During storage, the all-in-one admixture maintained its colour. No precipitation, flocculation or creaming was observed. The pH and average particle size did not change significantly. There were no adverse clinical events related to the all-in-one admixture after continuous infusion for 5 days. Conclusion: The all-in-one admixture containing Venolipid MCT/LCT 20% can be stored at 4 °C for 1 week and safely used in patients after major upper abdominal surgery. Crown