Back to resultsSafety and Efficacy of Longterm HPN With Two Lipid Emulsions
Primary Purpose
Malnutrition
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Lipoplus
Lipofundin MCT
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition focused on measuring HPN, lipid emulsion, long term, insufficient enteral resorption capacity
Eligibility 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
Sites / Locations
- Charité - Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
treatment with Lipoplus & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
treatment with Lipofundin MCT & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
Outcomes
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
Secondary Outcome Measures
Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition
Full Information
NCT ID
NCT00530738
First Posted
September 14, 2007
Last Updated
July 17, 2014
Sponsor
B. Braun Melsungen AG
1. Study Identification
Unique Protocol Identification Number
NCT00530738
Brief Title
Safety and Efficacy of Longterm HPN With Two Lipid Emulsions
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Melsungen AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
HPN, lipid emulsion, long term, insufficient enteral resorption capacity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
treatment with Lipoplus & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
Arm Title
2
Arm Type
Active Comparator
Arm Description
treatment with Lipofundin MCT & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
Intervention Type
Drug
Intervention Name(s)
Lipoplus
Intervention Description
i.v. fat emulsion for parenteral nutrition
Intervention Type
Drug
Intervention Name(s)
Lipofundin MCT
Intervention Description
i.V. fat emulsion for parenteral nutrition
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Thul, MD
Organizational Affiliation
Charité, University Hospital Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
30501620
Citation
Bohnert H, Maurer M, Calder PC, Pratschke J, Thul P, Muller V. Efficacy of a long-term home parenteral nutrition regimen containing fish oil-derived n-3 polyunsaturated fatty acids: a single-centre, randomized, double blind study. Nutr J. 2018 Nov 30;17(1):113. doi: 10.1186/s12937-018-0419-x.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Longterm HPN With Two Lipid Emulsions
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