Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-04-30

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.

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Detailed Description

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Conditions

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Parenteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

fish oil containing lipid emulsion

Group Type EXPERIMENTAL

fish oil containing lipid emulsion

Intervention Type DRUG

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

2

MCT/LCT containing lipid emulsion

Group Type ACTIVE_COMPARATOR

MCT/LCT containing lipid emulsion

Intervention Type DRUG

medium chain triglycerides, long chain triglycerides

Interventions

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fish oil containing lipid emulsion

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

Intervention Type DRUG

MCT/LCT containing lipid emulsion

medium chain triglycerides, long chain triglycerides

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No