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

Inclusion criteria

• Age ≥ 18 years and < 90 years, male or female
• Critically ill, medical or surgical intensive care unit (ICU) patient
• The patient was admitted to the ICU during the previous 24-48 hours and has a minimum expected ICU stay of 5 days after the completion of screening
• Central venous access available for continuous infusion of the investigational product
• Contraindication against EN or limited tolerance to EN; it is planned that the patient receives ≥75% of the total target caloric intake from PN during the 5 investigational product treatment days
• Informed consent (signed and dated) from the patient to participate in this clinical trial. If the patient is unable to make a decision because of his/her critical condition, a decision regarding study enrolment is made at a case conference involving three physicians

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.