NCT00530738

Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

Efficacy, Safety and Quality of Life of a Long-term Home Parenteral Nutrition Regimen With Either LIPIDEM® or LIPOFUNDIN® MCT a Mono-center, Randomized, Double Blind Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Long term parenteral nutrition is indicated in the home care setting of patients who are unable to completely cover their daily caloric requirements by oral/enteral nutrition due to e.g. pre existing malnutrition or compromised intestinal absorption. An appropriate nutritional supplementation ensuring the provision of patients basic requirement of amino acids, glucose, lipids, micronutrients and electrolytes is therefore required to stop weight loss, increase quality of life and to reduce unfavorable consequences of malnutrition in those patients. Major causes for malnutrition and compromised intestinal absorption are malignant processes. Tumor cachexia, weight loss due to insufficient nutrition of \< 60 -80 % of the calculated substrate need for \> 14 days, antineoplastic therapy and surgical intervention are consequences of the malignant disease and lead to catabolic processes.

Conditions

• Malnutrition

Interventions

Type	Name	Description
DRUG	Lipoplus	i.v. fat emulsion for parenteral nutrition
DRUG	Lipofundin MCT	i.V. fat emulsion for parenteral nutrition

Timeline

• Start date: 2007-09-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2007-09-17
• Last updated: 2014-07-18

Locations

1 site across 1 country: Germany