Parenteral NutritionPhase 3NCT01176695
Efficacy and Safety of a Fish Oil Containing Lipid Emulsion
A Phase 3 study testing fish oil containing lipid emulsion and MCT/LCT containing lipid emulsion in people with Parenteral Nutrition, run by B. Braun Melsungen AG at 2 sites in China.
Trial summary
The purpose of the study is to compare a fish oil containing lipid emulsion against a medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and safety during postoperative parenteral nutrition. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- fish oil containing lipid emulsion and MCT/LCT containing lipid emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2010to Apr 2011
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients considered for open abdominal surgery of moderate severity, e.g.. radical operation for stomach cancer or pancreaticoduodenal surgery
- Male and female patients ≥18 and <85 years of age
- Indication for total parenteral nutrition therapy: for at least 5 consecutive days after operation
- Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study.
Who cannot join
- General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid intake and output, inadequate cellular oxygen supply)
- General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency
- Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
- Other
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Double Blind, Controlled, Parallel Group, Multicenter Study on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion vs. a Medium and Long Chain Lipid Emulsion in Patients Undergoing Elective Abdominal Surgery of Moderate Severity
The purpose of the study is to compare a fish oil containing lipid emulsion against a medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and safety during postoperative parenteral nutrition.
- Conditions
- Parenteral Nutrition
- Being tested
- fish oil containing lipid emulsion, MCT/LCT containing lipid emulsion
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oil containing lipid emulsionDrug
medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides
MCT/LCT containing lipid emulsionDrug
medium chain triglycerides, long chain triglycerides
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fish oil containing lipid emulsion Receives: Drug: fish oil containing lipid emulsion |
| 2 | Active comparator | MCT/LCT containing lipid emulsion Receives: Drug: MCT/LCT containing lipid emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate on the efficacy of fish oil on the nutrition status
Prealbumin as the primary endpoint variable
Measured: day 1 to day 6
To investigate on the efficacy of fish oil on an inflammatory parameter
LTB5/LTB4 as a second primary endpoint
Measured: day 1 to day 6
Secondary outcomes (5)
Incidence of postoperative complications
Measured: 6 days
Liver function
Measured: 6 days
Coagulation parameters
Measured: 6 days
Blood chemistry
Measured: 6 days
SIRS
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionApr 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ning Li, Prof. MD. PhD., Principal investigator, Nanjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176695
- Sponsor's protocol ID
- HC-G-H-0802
- Status last verified
- Jan 2012
- First submitted
- 10 May 2010
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Controlled, Parallel Group, Multicenter Study on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion vs. a Medium and Long Chain Lipid Emulsion in Patients Undergoing Elective Abdominal Surgery of Moderate Severity
- ClinicalTrials.gov ID
- NCT01176695
- Acronym / sponsor ID
- HC-G-H-0802
- Conditions
- Parenteral Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 Aug 2010 (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.
The purpose of the study is to compare a fish oil containing lipid emulsion against a medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and safety during postoperative parenteral nutrition.
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: fish oil containing lipid emulsionfish oil containing lipid emulsion |
| 2 | Active comparator | Drug: MCT/LCT containing lipid emulsionMCT/LCT containing lipid emulsion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients considered for open abdominal surgery of moderate severity, e.g.. radical operation for stomach cancer or pancreaticoduodenal surgery
- Male and female patients ≥18 and <85 years of age
- Indication for total parenteral nutrition therapy: for at least 5 consecutive days after operation
- Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study.
Key exclusion criteria (4 listed)
- General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid intake and output, inadequate cellular oxygen supply)
- General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency
- Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
- Other
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 |
|---|---|---|
| fish oil containing lipid emulsionmedium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides | Drug | 1 |
| MCT/LCT containing lipid emulsionmedium chain triglycerides, long chain triglycerides | Drug | 2 |
Primary outcome
To investigate on the efficacy of fish oil on the nutrition status
Time frame: day 1 to day 6
Prealbumin as the primary endpoint variable
To investigate on the efficacy of fish oil on an inflammatory parameter
Time frame: day 1 to day 6
LTB5/LTB4 as a second primary endpoint
5 secondary outcomes
Incidence of postoperative complications
Time frame: 6 days
Liver function
Time frame: 6 days
Coagulation parameters
Time frame: 6 days
Blood chemistry
Time frame: 6 days
SIRS
Time frame: 6 days
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 10 Jan 2012.
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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.
Ning Li, Prof. MD. PhD. principal investigator
Nanjing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fish oil containing lipid emulsion and MCT/LCT containing lipid emulsion in people with Parenteral Nutrition, run by B. Braun Melsungen AG at 2 sites in China.
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 4 inclusion and 4 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 10 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To investigate on the efficacy of fish oil on the nutrition status (time frame: day 1 to day 6). The study lists 2 primary outcomes in all. 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 10 Jan 2012.