Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care

Exclusion Criteria

• •Contraindication against PN or inability to receive PN via central venous access
• •The patient has received PN within the last 7 days before the start of screening
• •Body mass index (BMI) \<18.5 kg/m2 or \>35 kg/m2
• •Any severe, persistent blood coagulation disorder with uncontrolled bleeding
• •Any congenital errors of amino acid metabolism
• •Uncontrolled hyperglycaemia despite insulin treatment
• •Known hypersensitivity to fish, egg, soybean proteins, peanut proteins, or to any of the active ingredients or excipients contained in SmofKabiven extra Nitrogen
• •General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency
• •Severe renal insufficiency defined by the following criteria:
• •* serum creatinine level \> 353.6 µmol/L, or
• •* creatinine level ≥ 3.0 times higher than the upper limit of normal (according to the KDIGO 2012 Clinical Practice Guideline), or
• •* diuresis \< 0.3 mL/kg/hr during ≥ 12 hrs (Acute Kidney Injury stage ≥ 3 according to the KDIGO 2012 Clinical Practice Guideline) without access to renal replacement therapy
• •Unstable haemodynamic conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock) including acute shock (arterial serum lactate \> 2.0 mmol/L)
• •Severe liver insufficiency
• •Haemophagocytic syndrome
• •Pregnancy or lactation
• •Receiving end-of-life care
• •Severe hyperlipidaemia (serum cholesterol and/or triglycerides and/or LDL-C level at least 1.5 times higher than the upper limit of normal range)
• •Pathologically elevated serum levels of any of the included electrolytes (sodium, potassium, magnesium, total calcium, chloride, inorganic phosphate)
• •Participation in another interventional clinical trial within the previous 4 weeks
• •Previous inclusion in the present study.