Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

Malnutrition Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition

• NCT number: NCT00530738
• Study type: Interventional
• Source: B. Braun Melsungen AG
• Status: Completed
• Phase: Phase 4
• Start date: September 2007
• Completion date: January 2014