Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Malnutrition

Intervention / Treatment
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* Drug: Lipoplus
* Drug: Lipofundin MCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Age: 18-80 years Male and female patients Patients with a newly indicated need of long-term home parenteral nutrition (HPN) for at least 8 weeks Patients with an insufficient resorption capacity of the colon that may not be compensated by enteral nutrition mentally and physically able to adhere to study procedures. Females agree to apply adequate contraception Exclusion Criteria: Participation in a clinical study with an investigational drug within one month prior to the start of study Patients with sepsis, severe sepsis and septic shock Known or suspected drug abuse General contra indications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency Pregnancy and lactation Autoimmune disease as e.g. HIV Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure) Alterations of coagulation (thrombocytes <150.000 mm3), PT < 50%, PTT > 40 sec Diabetes mellitus with known ketoacidosis within 7 days before onset of study Renal insufficiency with serum creatinine > 1.4 mg/dL(>124 mmol/L) Patients with severe liver dysfunction with bilirubin >2.5 mg/dL (> 43 µmol/L) Lipid disorders, in particular fasting serum triglycerides > 250 mg/dL (>2.86 mmol/L) necrotizing pancreatitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>treatment with Lipoplus & Nutriflex plus (commercially available and marketed 2 Chamber Bag) | Drug: Lipoplus<br>* i.v. fat emulsion for parenteral nutrition<br>|
| Active Comparator: 2<br>treatment with Lipofundin MCT & Nutriflex plus (commercially available and marketed 2 Chamber Bag) | Drug: Lipofundin MCT<br>* i.V. fat emulsion for parenteral nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPN, lipid emulsion, long term, insufficient enteral resorption capacity