A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.
Inclusion Criteria:
- Patients considered for major surgery for gastric and colorectal cancer
- expected requirement for post operative PN or TPN of at least 7 days
- possibility of PN/TPN provision 1 day prior to surgery
- Age >18 years old and <80 years old
- Hemodynamically stable
- Written Informed consent
Exclusion Criteria:
- Participation in a clinical study with an investigational drug or an investigational
medical device within one month prior to the start of study
- Patients with sepsis, severe sepsis or septic shock
- Known or suspected drug abuse
- Intrahepatic cholestasis
- General contraindications for infusion therapy such as acute pulmonary edema,
hyperhydration and decompensated cardiac insufficiency
- Pregnancy (positive in urine) or lactation
- Autoimmune disease e.g. HIV
- Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients of
the investigational products
- Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac
failure)
- Alterations of coagulation (thrombocytes <150000 /mm3), PT < 50%, PTT > 40 sec
- Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
- Renal insufficiency with serum creatinine > 1.4 mg/dL (>124 µmol/L)
- Patients with severe liver dysfunction with bilirubin >2.5 mg/dL (> 43 µmol/L)
- Lipid disorders, in particular fasting serum triglycerides > 250 mg/dL (>2.85
mmol/L),