Safety and efficacy of a new parenteral lipid emulsion (SMOFlipid) in surgical patients: a randomized, double-blind, multicenter study.

BACKGROUND/AIMS: A new lipid emulsion based on soybean oil, medium chain triglycerides, olive oil and fish oil (SMOFlipid) was tested for safety, tolerance, metabolic and clinical efficacy in surgical patients.

METHODS

In a prospective, double-blind European multicenter study, postoperative patients (elective abdominal or thoracic surgery) were randomized to receive isonitrogenous, isoenergetic (30-35 kcal/kg) total parenteral nutrition over 5 postoperative days including either SMOFlipid 20% or standard soybean oil emulsion (Lipovenoes 20%) as lipid source (1.5 g kg(-1) day(-1)). Metabolic efficacy measurements included serum levels of triglycerides (AUC), phospholipids, and total cholesterol. Safety/tolerance parameters were: hematology; clinical chemistry; coagulation profile; clinical course (arterial blood pressure, heart rate, body temperature), and documentation of adverse events. Clinical efficacy was monitored by length of hospital stay and mortality.

RESULTS

The 2 groups (per-protocol population: SMOFlipid n = 99, and Lipovenoes n = 100) were similar with respect to demographic characteristics and types of surgical intervention. Concentrations of serum triglycerides, phospholipids, and total cholesterol were comparable in both groups and within the expected ranges. Laboratory and clinical parameters were not different. A trend towards a reduced length of hospital stay was observed with SMOFlipid (15.7 +/- 6.3 vs. 17.8 +/- 13.2 days).

CONCLUSIONS

SMOFlipid is clinically safe and well tolerated in postoperative patients. There are indications that SMOFlipid may be associated with a better liver tolerance and a shorter length of hospitalization.