Clinical trial NCT00530738: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Keywords: HPN
lipid emulsion
long term
insufficient enteral resorption capacity
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI
timeFrame: 8 weeks
Secondary outcomes:
measure: Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charité, University Hospital Berlin
name: Paul Thul, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.