Safety and Efficacy of Longterm HPN With Two Lipid Emulsions - Full Text View

Sponsor:	B. Braun Melsungen AG
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00530738

Purpose

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:	Allocation: Randomized Control: Active Control Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition

Drug Information available for: Lipids

U.S. FDA Resources

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (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)	Drug: Lipoplus i.v. fat emulsion for parenteral nutrition
2: Active Comparator treatment with Lipofundin MCT & Nutriflex plus (commercially available and marketed 2 Chamber Bag)	Drug: Lipofundin MCT i.V. fat emulsion for parenteral nutrition

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530738

Contacts

Contact: Paul Thul, MD

+49 30 4505 ext 22170

Paul.Thul@charite.de

Locations

Germany
Charité - Universitätsmedizin Berlin	Recruiting
Berlin, Germany, 10117
Principal Investigator: Paul Thul, MD

Sponsors and Collaborators

B. Braun Melsungen AG

Investigators

Principal Investigator:

Paul Thul, MD

Charité, University Hospital Berlin

More Information

No publications provided

Responsible Party:	Charité ( PD Dr. P. Thul )
ClinicalTrials.gov Identifier:	NCT00530738 History of Changes
Other Study ID Numbers:	HC-G-H-0503, EudraCT-Nr.: 2005-001938-32
Study First Received:	September 14, 2007
Last Updated:	February 4, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by B. Braun Melsungen AG:

HPN
lipid emulsion
long term
insufficient enteral resorption capacity

Additional relevant MeSH terms:

Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 07, 2010