drugset / Trial / NCT00530738

Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

NCT00530738 ↗

Phase 4 Completed 42 enrolled B. Braun Melsungen AG
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

EvaluationDrugModalityDoseRoute
Comparator Lipofundin MCT Other / unclassified — Intravenous
Subject Lipoplus Other / unclassified — Intravenous