Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00530738
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : July 18, 2014
Information provided by (Responsible Party):
B. Braun Melsungen AG

Brief 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.

Condition or disease Intervention/treatment Phase
Malnutrition Drug: Lipoplus Drug: Lipofundin MCT Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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
Study Start Date : September 2007
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: 1
treatment with Lipoplus & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
Drug: Lipoplus
i.v. fat emulsion for parenteral nutrition
Active Comparator: 2
treatment with Lipofundin MCT & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
Drug: Lipofundin MCT
i.V. fat emulsion for parenteral nutrition

Primary Outcome Measures :
  1. Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00530738

Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
B. Braun Melsungen AG
Principal Investigator: Paul Thul, MD Charité, University Hospital Berlin

Responsible Party: B. Braun Melsungen AG Identifier: NCT00530738     History of Changes
Other Study ID Numbers: HC-G-H-0503
EudraCT-Nr.: 2005-001938-32
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by B. Braun Melsungen AG:
lipid emulsion
long term
insufficient enteral resorption capacity

Additional relevant MeSH terms:
Nutrition Disorders
Gastrointestinal Agents