The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Lipoplus i.v. lipid emulsion for parenteral nutrition
Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Hôpital Archet 2 - Unité de support nutritionnel
Nice, France
Hospices Civiles de Lyon - Centre hospitalier Lyon Sud
Pierre-Bénite, France
Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital
Bologna, Italy
Change of Liver Function Parameters From Baseline to Visit 2
Changes will be expressed as the sum of the N(0.1)- transformed differences of bilirubin, ALT and AST (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters.
Time frame: 8 weeks
Bilirubin
Change from baseline
Time frame: 8 weeks
Alanine Transaminase (ALT)
Change from baseline
Time frame: 8 weeks
Aspartate Transaminase (AST)
Change from baseline
Time frame: 8 weeks
AST/ALT Ratio
Change from baseline
Time frame: 8 weeks
Alkaline Phosphatase (ALP)
Change from baseline
Time frame: 8 weeks
Gamma-glutamyl Transpeptidase (GGT)
Change from baseline
Time frame: 8 weeks
White Blood Cells (WBCs)
Change from baseline
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Radboud university medical center
Nijmegen, Netherlands
Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej
Lodz, Poland
Stanley Dudrick's Memorial Hospital
Skawina, Poland
Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii
Warsaw, Poland
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
University College Hospital London
London, United Kingdom
Red Blood Cells (RBCs)
Change from baseline
Time frame: 8 weeks
Hemoglobin (Hb)
Change from baseline
Time frame: 8 weeks
Platelets
Change from baseline
Time frame: 8 weeks
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)
Change from baseline
Time frame: 8 weeks
Activated Partial Thromboplastin Time (aPTT)
Change from baseline
Time frame: 8 weeks
Hematocrit (Hct)
Change from baseline
Time frame: 8 weeks
Blood Glucose
Change from baseline
Time frame: 8 weeks
Sodium
Change from baseline
Time frame: 8 weeks
Chloride
Change from baseline
Time frame: 8 weeks
Potassium
Change from baseline
Time frame: 8 weeks
Calcium
Change from baseline
Time frame: 8 weeks
Magnesium
Change from baseline
Time frame: 8 weeks
Phosphate
Change from baseline
Time frame: 8 weeks
Serum Creatinine
Change from baseline
Time frame: 8 weeks
Triglycerides
Change from baseline
Time frame: 8 weeks
Cholesterol
Change from baseline
Time frame: 8 weeks
High-density Lipoprotein (HDL)
Change from baseline
Time frame: 8 weeks
Low-density Lipoprotein (LDL)
Change from baseline
Time frame: 8 weeks
C-reactive Protein (CRP)
Change from baseline
Time frame: 8 weeks
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)
Change from baseline
Time frame: 8 weeks
Triene:Tetraene Ratio in Plasma, Reduction From Baseline
Derived from fatty acid pattern in plasma
Time frame: 8 weeks
Adverse Events
Number of adverse events (including serious adverse events)
Time frame: 8 weeks
BMI
Body mass index Change from baseline
Time frame: 8 weeks
Prothrombin Time (PT)
Change from baseline
Time frame: 8 weeks