Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01176695

Enrollment

240

Registered

2010-08-06

Start date

2010-04-30

Completion date

2011-04-30

Last updated

2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenteral Nutrition

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
To investigate on the efficacy of fish oil on the nutrition status	day 1 to day 6	Prealbumin as the primary endpoint variable
To investigate on the efficacy of fish oil on an inflammatory parameter	day 1 to day 6	LTB5/LTB4 as a second primary endpoint

Secondary

Measure	Time frame
Coagulation parameters	6 days
Incidence of postoperative complications	6 days
SIRS	6 days
Blood chemistry	6 days
Liver function	6 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026