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Sponsored by: |
B. Braun Melsungen AG |
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Information provided by: | B. Braun Melsungen AG |
ClinicalTrials.gov Identifier: | NCT00530738 |
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.
Condition | Intervention | Phase |
---|---|---|
Malnutrition |
Drug: Lipoplus Drug: Lipofundin MCT |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment |
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 |
Estimated Enrollment: | 66 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
treatment with Lipoplus & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
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Drug: Lipoplus
i.v. fat emulsion for parenteral nutrition
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2: Active Comparator
treatment with Lipofundin MCT & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
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Drug: Lipofundin MCT
i.V. fat emulsion for parenteral nutrition
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul Thul, MD | +49 30 4505 ext 22170 | Paul.Thul@charite.de |
Germany | |
Charité - Universitätsmedizin Berlin | Recruiting |
Berlin, Germany, 10117 | |
Principal Investigator: Paul Thul, MD |
Principal Investigator: | Paul Thul, MD | Charité, University Hospital Berlin |
Responsible Party: | Charité ( PD Dr. P. Thul ) |
Study ID Numbers: | HC-G-H-0503, EudraCT-Nr.: 2005-001938-32 |
Study First Received: | September 14, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00530738 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
HPN lipid emulsion long term insufficient enteral resorption capacity |
Malnutrition Quality of Life Nutrition Disorders |