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CompletedNCT01176695Updated Jan 10, 2012

Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

A Phase 3 interventional study of fish oil containing lipid emulsion and MCT/LCT containing lipid emulsion in Parenteral Nutrition, sponsored by B. Braun Melsungen AG. Completed at 2 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-01-10.

Sponsored by B. Braun Melsungen AG · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parenteral Nutrition
03

In context

Lead sponsor

B. Braun Melsungen AG is the lead sponsor of 46 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    1

    fish oil containing lipid emulsion

    Drug: fish oil containing lipid emulsion

  • Active comparator
    2

    MCT/LCT containing lipid emulsion

    Drug: MCT/LCT containing lipid emulsion

Interventions

  • Drugfish oil containing lipid emulsion

    medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides

  • DrugMCT/LCT containing lipid emulsion

    medium chain triglycerides, long chain triglycerides

06

What researchers measure

Primary outcomes

  1. To investigate on the efficacy of fish oil on the nutrition status

    Prealbumin as the primary endpoint variable

    Time frame: day 1 to day 6

  2. To investigate on the efficacy of fish oil on an inflammatory parameter

    LTB5/LTB4 as a second primary endpoint

    Time frame: day 1 to day 6

Secondary outcomes

  1. Incidence of postoperative complications

    Time frame: 6 days

  2. Liver function

    Time frame: 6 days

  3. Coagulation parameters

    Time frame: 6 days

  4. Blood chemistry

    Time frame: 6 days

  5. SIRS

    Time frame: 6 days

07

Study locations

2 sites
  • Hospitals
    Beijing, 100730, China
  • Nanjing Hospital
    Nanjing, 210002, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01176695
Lead sponsor
B. Braun Melsungen AG
Responsible party
Sponsor
First posted
Aug 6, 2010
Start date
Apr 2010
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Jan 10, 2012

Study contacts

Ning Li, Prof. MD. PhD.
principal investigator · Nanjing Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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