The trial aims at providing patients with insufficient absorption capacity, that may not be compensated by enteral nutrition, with the required amount of caloric supply. The insufficient absorption capacity may a multiple reasons. The majority of patients will be oncologic patients. MedDRA version: 14.1 Level: PT Classification code 10051284 Term: Parenteral nutrition System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Lipidem 20%
Pharmaceutical Form: Emulsion for infusion
Other descriptive name: soy bean oil
Concentration unit: % percent
Concentration type: equal
Concentration number: 8-
Other descripti
Sponsors
B.Braun Melsungen AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a need of long-term home parenteral nutrition (HPN) for at least 8 weeks - Age >18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 42
Exclusion criteria
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 contraindications for infusion therapy such as acute pulmonary oedema, hyper hydration and decompensated cardiac insufficiency - Pregnancy (positive in urine) and lactation - Autoimmune disease e.g. HIV - Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients - Haemodynamical failure of any origin (haemorrhagic shock, myocardial infarction, cardiac failure) - Alterations of coagulation (thrombocytes 40 sec - Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study - Renal insufficiency with serum creatinine >1.4 mg/dL (>124 µmol/L). In a range from 1.4 mg/dL (124 µmol/L) to 2.4 mg/dL (212 µmol/L) it is a decision of the physician depending on the kind of disease, the physical constitution and the indivudual need of the patient. - 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). In a range from 250 mg/dL (2.86 mmol/L) to 300 mg/dL (3.43 mmol/L) it is a decision of the physician depending on the kind of disease, the physical constitution and the individual need of the patient. - Necrotizing pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of noninferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI.;Secondary Objective: Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition.;Primary end point(s): It is anticipated that the nutritional status of patients being provided with a HPN regimen containing n-3 PUFA is non inferior to that of patients being provided with a HPN regimen without n-3 PUFA. It is expected that patients receiving n-3 PUFA will show a similar evolution of their BMI compared to patients receiving the standard lipid emulsion without n-3 PUFA. ;Timepoint(s) of evaluation of this end point: Baseline, after 4 weeks, after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: IL-6, IL-10, CRP, TNFa , Body Cell Mass (BCM), Indirect Calorimetry, Safety & Further: ALT, AST, gGT, AP, PT, aPTT, ostase Adverse Events, Vitamin E, Transferrin, Albumin, Triglyceride, Cholesterol, Creatinine, Urea, Bilirubin, Lactate, Hemoglobin, Hematocrit, Glucose, Leukocytes, Platelets, Erythrocytes, pH, Na+, K+, Ca++, Mg++, Cl-, anamnesis, anamnestic peculiarities, physical examination, vital signs Quality of life: EORTC QLQ-C30 ;Timepoint(s) of evaluation of this end point: Baseline, after 4 weeks, after 8 weeks | — |
Countries
Germany
Contacts
Public ContactClinical Development
B. Braun Melsungen AG
Outcome results
None listed