MalnutritionPhase 4NCT00530738
Safety and Efficacy of Longterm HPN With Two Lipid Emulsions
A Phase 4 study testing Lipoplus and Lipofundin MCT in people with Malnutrition, run by B. Braun Melsungen AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Lipoplus and Lipofundin MCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Lipoplus, Lipofundin MCT
- Keywords
- HPN, lipid emulsion, long term, insufficient enteral resorption capacity
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoplusDrug
i.v. fat emulsion for parenteral nutrition
Lipofundin MCTDrug
i.V. fat emulsion for parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | treatment with Lipoplus \& Nutriflex plus (commercially available and marketed 2 Chamber Bag) Receives: Drug: Lipoplus |
| 2 | Active comparator | treatment with Lipofundin MCT \& Nutriflex plus (commercially available and marketed 2 Chamber Bag) Receives: Drug: Lipofundin MCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI
Measured: 8 weeks
Secondary outcomes (1)
Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Thul, MD, Principal investigator, Charité, University Hospital Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530738
- Sponsor's protocol ID
- HC-G-H-0503
- Other IDs
- EudraCT-Nr.: 2005-001938-32
- Status last verified
- Jul 2014
- First submitted
- 14 Sep 2007
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30501620
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00530738
- Acronym / sponsor ID
- HC-G-H-0503
- Conditions
- Malnutrition
- Keywords
- HPN, lipid emulsion, long term, insufficient enteral resorption capacity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lipoplustreatment with Lipoplus \& Nutriflex plus (commercially available and marketed 2 Chamber Bag) |
| 2 | Active comparator | Drug: Lipofundin MCTtreatment with Lipofundin MCT \& Nutriflex plus (commercially available and marketed 2 Chamber Bag) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipoplusi.v. fat emulsion for parenteral nutrition | Drug | 1 |
| Lipofundin MCTi.V. fat emulsion for parenteral nutrition | Drug | 2 |
Primary outcome
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
1 secondary outcome
Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Derived from this study: PubMed 30501620Bohnert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Thul, MD principal investigator
Charité, University Hospital Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipoplus and Lipofundin MCT in people with Malnutrition, run by B. Braun Melsungen AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00530738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.