Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parenteral Nutrition

Intervention / Treatment
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* Drug: fish oil containing lipid emulsion
* Drug: MCT/LCT containing lipid emulsion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>fish oil containing lipid emulsion | Drug: fish oil containing lipid emulsion<br>* medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides<br>|
| Active Comparator: 2<br>MCT/LCT containing lipid emulsion | Drug: MCT/LCT containing lipid emulsion<br>* medium chain triglycerides, long chain triglycerides<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative complications |  | 6 days | 
| Liver function |  | 6 days | 
| Coagulation parameters |  | 6 days | 
| Blood chemistry |  | 6 days | 
| SIRS |  | 6 days |