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

Launched by FRESENIUS KABI · Feb 16, 2022

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Eligibility criteria

• 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.