Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Exclusion Criteria

• •1. Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior to study participation
• •2. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of SMOFlipid.
• •3. Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \>250 mg/dL in infants or \>400 mg/dL in older pediatric and adult patients).
• •4. Inborn errors of amino acid metabolism.
• •5. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support).
• •6. Hemophagocytic syndrome.
• •7. Liver enzymes (either AST, or ALT, or GGT) exceeding 2 x upper limit of normal range
• •8. Direct bilirubin exceeding 2 x upper limit of normal range
• •9. INR exceeding 2 x upper limit of normal range and patient not receiving oral anticoagulants.
• •10. Any known hepatic condition outside of IFALD that will increase direct bilirubin ≥2.0 mg/dL.
• •11. Clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate).
• •12. Active bloodstream infection demonstrated by positive blood culture at screening.
• •13. Severe renal failure (eGFR \<15 ml/min per 1.73 m2) including patients on renal replacement therapy.
• •14. Abnormal blood pH, oxygen saturation, or carbon dioxide.
• •15. Pregnancy or lactation.
• •16. Participation in another interventional clinical study.
• •17. Unlikely to survive longer than 56 days.