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Completed

NCT Number: NCT01176695

Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

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.

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Key information

Conditions

Parenteral Nutrition Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospitals, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fish oil containing lipid emulsion

Drug

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

MCT/LCT containing lipid emulsion

Drug

medium chain triglycerides, long chain triglycerides

Primary outcomes

  1. 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

  2. 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

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

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2010
Registry last updated
Jan 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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