Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530738
• Other study ID #: HC-G-H-0503
• Secondary ID: EudraCT-Nr.: 200
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2007
• Last updated: July 17, 2014
• Start date: September 2007
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition

Intervention

Drug:
• Lipoplus
i.v. fat emulsion for parenteral nutrition
• Lipofundin MCT
i.V. fat emulsion for parenteral nutrition

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI		8 weeks	No
Secondary	Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition		8 weeks	No