NCT00530738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

6.3 years

First QC Date

September 14, 2007

Last Update Submit

July 17, 2014

Conditions

Malnutrition

Keywords

HPNlipid emulsionlong terminsufficient enteral resorption capacity

Outcome Measures

Primary Outcomes (1)

  • Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI

    8 weeks

Secondary Outcomes (1)

  • Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Lipoplus

2

ACTIVE COMPARATOR

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

Drug: Lipofundin MCT

Interventions

LipoplusDRUG

i.v. fat emulsion for parenteral nutrition

1
Lipofundin MCTDRUG

i.V. fat emulsion for parenteral nutrition

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30501620DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Paul Thul, MD

    Charité, University Hospital Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2007

First Posted

September 17, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

DE(1)