At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition (PN): A Randomized, Active-Controlled, Patient-blinded, Multi-Centre Study in Adult Surgical Patients Requiring PN
In Brief
A Phase 3 clinical trial evaluating SmofKabiven emulsion for infusion and Hospital compounded "All in one" emulsion for Parenteral Nutrition and Surgery. Completed, enrolled 273 participants across 8 sites.
Detailed Summary
The present protocol describes a randomized, patient-blinded study in which either SmofKabiven emulsion for infusion or a hospital compounded "All in one" control Total Parenteral Nutrition (TPN) regimen will be given to adult surgical patients for 5 consecutive days. As serum prealbumin is a well-established surrogate efficacy parameter reflecting the patient´s nutritional status, the change of the serum prealbumin level at the day of the final study visit compared to baseline will represent the primary efficacy parameter in the present study.
Study Details
Timeline
Interventions
Total Parenteral Nutrition
Total Parenteral Nutrition