Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

Phase 3

Completed

• Conditions: Parenteral Nutrition
• Interventions: Drug: fish oil containing lipid emulsion; Drug: MCT/LCT containing lipid emulsion

• Registration Number: NCT01176695
• Lead Sponsor: B. Braun Melsungen AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fish oil containing lipid emulsion	fish oil containing lipid emulsion
2	MCT/LCT containing lipid emulsion	MCT/LCT containing lipid emulsion

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of postoperative complications	6 days
Liver function	6 days
Coagulation parameters	6 days
Blood chemistry	6 days
SIRS	6 days

Trial Locations

Locations (2)

Hospitals; 🇨🇳 Beijing, China

Nanjing Hospital; 🇨🇳 Nanjing, China