Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

B. Braun

Status and phase

Completed

Phase 3

Conditions

Parenteral Nutrition

Treatments

Drug: fish oil containing lipid emulsion

Drug: MCT/LCT containing lipid emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT01176695

HC-G-H-0802

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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