Parenteral NutritionPhase 4NCT01814956
Different Lipid Emulsions in Acute Lung Injury Patients
A Phase 4 study testing Lipoplus 20% and Lipofundin N 20% in people with Parenteral Nutrition, run by B. Braun Melsungen AG at 1 site in Germany.
Trial summary
Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- Lipoplus 20% and Lipofundin N 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to May 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration
- Oxygenation factor ≤ 300
- <= 72 hours since intubation or non-invasive ventilatory support by mask at screening
- Expected need for parenteral nutrition for at least 5 days
- Male or female ≥ 18 years of age
Who cannot join
- Exclusion of pregnancy in women with child-bearing potential
- Cardiogenic pulmonary oedema
- Previous (< 1 month) or ongoing need for corticosteroids >0.1 mg/kg/d prednisolon-equivalent or other immune suppressive treatment
- Active or previous (< 1 year) treatment for solid or haematologic malignancy
- Serum triglycerides > 300 mg/dl at screening
- Alterations of coagulation (thrombocytes <100 Giga/l), aPTT > 60 sec, INR ≥ 2.5 without therapeutic intervention
Show all 9Show fewer
- Autoimmune disease or HIV (according to medical history)
- Known or suspected drug abuse
- General contraindications to infusion therapy :
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Controlled, Double-blind, Parallel-group, Mono-center, Explorative Phase IV Trial on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion Versus a Standard Soybean-oil Based Lipid Emulsion in Patients With Acute Lung Injury
Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung injury.
- Conditions
- Parenteral Nutrition
- Being tested
- Lipoplus 20%, Lipofundin N 20%
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoplus 20%Drug
Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition
Lipofundin N 20%Drug
Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | i.v. lipid emulsion for parenteral nutrition Receives: Drug: Lipoplus 20% |
| 2 | Active comparator | i.v. lipid emulsion for parenteral nutrition Receives: Drug: Lipofundin N 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in blood oxygenation (PaO2/FiO2ratio)
Measured: change day 1 to day 6
Secondary outcomes (2)
Triglycerides
Measured: day 1 to day 16
Sequential Organ Failure Assessment
Measured: day 1 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral NutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814956
- Sponsor's protocol ID
- HC-G-H-0813
- Other IDs
- 2011-003397-82
- Status last verified
- Jul 2016
- First submitted
- 18 Mar 2013
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Double-blind, Parallel-group, Mono-center, Explorative Phase IV Trial on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion Versus a Standard Soybean-oil Based Lipid Emulsion in Patients With Acute Lung Injury
- ClinicalTrials.gov ID
- NCT01814956
- Acronym / sponsor ID
- HC-G-H-0813
- Conditions
- Parenteral Nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Mar 2013 (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.
Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lipoplus 20%i.v. lipid emulsion for parenteral nutrition |
| 2 | Active comparator | Drug: Lipofundin N 20%i.v. lipid emulsion for parenteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration
- Oxygenation factor ≤ 300
- <= 72 hours since intubation or non-invasive ventilatory support by mask at screening
- Expected need for parenteral nutrition for at least 5 days
- Male or female ≥ 18 years of age
Key exclusion criteria (9 listed)
- Exclusion of pregnancy in women with child-bearing potential
- Cardiogenic pulmonary oedema
- Previous (< 1 month) or ongoing need for corticosteroids >0.1 mg/kg/d prednisolon-equivalent or other immune suppressive treatment
- Active or previous (< 1 year) treatment for solid or haematologic malignancy
- Serum triglycerides > 300 mg/dl at screening
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 |
|---|---|---|
| Lipoplus 20%Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition | Drug | 1 |
| Lipofundin N 20%Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition | Drug | 2 |
Primary outcome
change in blood oxygenation (PaO2/FiO2ratio)
Time frame: change day 1 to day 6
2 secondary outcomes
Triglycerides
Time frame: day 1 to day 16
Sequential Organ Failure Assessment
Time frame: day 1 to day 28
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
Related trials for Parenteral Nutrition
RecruitingPhase 1
First Time in Human Study of Long Acting VH4524184 Formulations
HIV Infections
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
Pulmonary Arterial Hypertension
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 20% and Lipofundin N 20% in people with Parenteral Nutrition, 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Jul 2016. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
change in blood oxygenation (PaO2/FiO2ratio) (time frame: change day 1 to day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2016.