The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
1-2 g, 5-7 days, 28 days
North Shore Private Hospital
Saint Leonards, New South Wales, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Aalborg University Hospital, Department of Medical Gastroenterology
Aalborg, Denmark
Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables
Time frame: day 0, week 2, week 4
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Rigshospitalet, Department of Medical Gastroenterology
Copenhagen, Denmark
Hopital Beaujon
Clichy, France
Hopital Edouard Herriot, Unite de Nutrition a Domicile Lyon
Lyon, France
Beilinson Medical Center, Department of Surgery "B"
Petah Tikva, Israel
University Medical Center
Nijmegen, Netherlands
Wydzial Lekarski I Katedra Chirurgii Ogolnej
Krakow, Poland
Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
Warsaw, Poland
...and 2 more locations