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

Launched by FRESENIUS KABI · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a treatment called SMOFlipid, which is used for patients who cannot eat normally and need to receive their nutrition through an intravenous method known as parenteral nutrition (PN). The study aims to determine whether patients, both children and adults, are at risk of developing specific health issues related to this form of nutrition, such as Essential Fatty Acid Deficiency (EFAD) and Parenteral Nutrition Associated Cholestasis (PNAC).

To be eligible for the trial, participants must be at least 1 month old and require PN for at least 5 days each week, receiving most of their energy through this method for at least 8 weeks. It's important that participants or their parents give written consent to join the study. Throughout the trial, participants will be monitored for any side effects or health changes related to the treatment. If you're considering participation, please discuss it with your healthcare provider to understand fully what it involves and whether it is a suitable option for you or your child.

Gender

ALL

Eligibility criteria

• • Age Limits: and Adults
• Inclusion Criteria:
• • 1. Male or female patients, at least 1 month of age.
• • 2. Patients who require PN for at least 5 days/week.
• • 3. Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total energy requirements as PN for at least 56 days.
• • 4. Written informed consent. In case of pediatric patients, informed consent must be obtained from parent(s) or legal representatives. If possible, the assent of the pediatric patient must also be obtained (according to local law).
• 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.