Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

NCT ID: NCT00530738

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-01-31

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.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

1

treatment with Lipoplus \& Nutriflex plus (commercially available and marketed 2 Chamber Bag)

Group Type: EXPERIMENTAL

Lipoplus

Intervention Type: DRUG

i.v. fat emulsion for parenteral nutrition

2

treatment with Lipofundin MCT \& Nutriflex plus (commercially available and marketed 2 Chamber Bag)

Group Type: ACTIVE_COMPARATOR

Lipofundin MCT

Intervention Type: DRUG

i.V. fat emulsion for parenteral nutrition

Interventions

Lipoplus

i.v. fat emulsion for parenteral nutrition

Intervention Type: DRUG

Lipofundin MCT

i.V. fat emulsion for parenteral nutrition

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Thul, MD

Role: PRINCIPAL_INVESTIGATOR

Charité, University Hospital Berlin

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 30501620 (View on PubMed)

Other Identifiers

EudraCT-Nr.: 2005-001938-32

Identifier Type: -

Identifier Source: secondary_id

HC-G-H-0503

Identifier Type: -

Identifier Source: org_study_id