Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00530738
First received: September 14, 2007
Last updated: July 17, 2014
Last verified: July 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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 ]

Enrollment: 42
Study Start Date: September 2007
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
treatment with Lipoplus & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
Drug: Lipoplus
i.v. fat emulsion for parenteral nutrition
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Paul Thul, MD Charité, University Hospital Berlin
  More Information

No publications provided

Responsible Party: B. Braun Melsungen AG
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: July 17, 2014
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 July 31, 2014