Status:
COMPLETED
Efficacy and Safety of a Fish Oil Containing Lipid Emulsion
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Parenteral Nutrition
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 postope...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01176695
Start Date
April 1 2010
End Date
April 1 2011
Last Update
January 10 2012
Active Locations (2)
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1
Hospitals
Beijing, China, 100730
2
Nanjing Hospital
Nanjing, China, 210002