Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

RECRUITING

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

Lead Sponsor:

Fresenius Kabi

Conditions:

Malnutrition, Child

Malnutrition

Eligibility:

All Genders

1-17 years

Phase:

PHASE4

Brief Summary

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipi...

Eligibility Criteria

Inclusion

  • Age Limits: and Adults
  • Male or female patients, at least 1 month of age.
  • Patients who require PN for at least 5 days/week.
  • 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.
  • 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

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

Key Trial Info

Start Date :

October 28 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06049680

Start Date

October 28 2024

End Date

September 1 2026

Last Update

December 4 2025

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Emory University Hospital

Atlanta, Georgia, United States, 30322

2

The University of Chicago

Chicago, Illinois, United States, 60638

3

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

4

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205