Evaluating the safety of SMOFlipid in preventing malnutrition-related complications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety of SMOFlipid, a lipid injectable emulsion, in both pediatric and adult patients who require long-term parenteral nutrition. Participants must be at least 1 month old and expected to receive parenteral nutrition for at least 56 days. The study aims to assess the risk of developing essential fatty acid deficiency (EFAD) and parenteral nutrition-associated cholestasis (PNAC) during treatment. By monitoring these patients, the study seeks to provide insights into the effectiveness of SMOFlipid in preventing these complications.

Why it matters

Who can join: the full rules

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.

Where it's running

• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Riley Hospital for Children
  Indianapolis, Indiana, United States Recruiting
• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting
• Children's Hospital of Pittsburgh of UPMC
  Pittsburgh, Pennsylvania, United States Recruiting
• The University of Chicago
  Chicago, Illinois, United States Terminated
• Duke University Medical Center
  Durham, North Carolina, United States Not yet recruiting

Study contacts

• Principal investigator: Jeffrey Rudolph, MD — University of Pittsburgh
• Study coordinator: Martin Stumpf, PhD
• Email: martin.stumpf@fresenius-kabi.com
• Phone: +49 6172 686

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.