Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

July 17, 2014 updated by: B. Braun Melsungen AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Paul Thul, MD, Charité, University Hospital Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 14, 2007

First Submitted That Met QC Criteria

September 14, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-G-H-0503
  • EudraCT-Nr.: 2005-001938-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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