drugset / Trial / NCT00530738
Safety and Efficacy of Longterm HPN With Two Lipid Emulsions
RandomizedParallel-groupDouble-blindSupportive care
Summary
It is the purpose of this trial to provide evidence for safety and efficacy of long term home parenteral nutrition with either Lipofundin MCT or Lipoplus in patients with proven insufficient enteral resorption.
Timeline
- Start
- 2007-09
- Primary completion
- 2014-01
- Completion
- 2014-01
Outcome
Met primary endpoint
paper BMI increased in both groups with 8 weeks of HPN (ΔBMI(test group) = 1.3 ± 1.1 kg/m2; ΔBMI(control group) = 0.6 ± 0.9 kg/m2) demonstrating non-inferiority of the test regimen regarding nutritional efficacy. PMID 30501620 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lipofundin MCT | Other / unclassified | — | Intravenous |
| Subject | Lipoplus | Other / unclassified | — | Intravenous |