Trial | NCT01819961  Report issue

Title

Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery
Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    fatty acid ...

  • Study Participants

    50
The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.
Postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count, biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°C pending analysis.

The primary endpoint was numbers of infective complications.Secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.
Study Started
Apr 30
2013
Primary Completion
Oct 31
2013
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Mar 28
2013
Estimate

Drug MCT/LCT and fish oil

  • Other names: Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) and fish oil (Omegaven,Fresenius-Kabi, Germany)

Drug MCT/LCT

  • Other names: Structural Fat Emulsion Injection (Fresenius-Kabi, Germany)

MCT/LCT Experimental

Structural Fat Emulsion Injection 250ml per day, for 7 days

MCT/LCT and fish oil Experimental

Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.

Criteria 

Inclusion Criteria:

Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition

Exclusion Criteria:

Metabolic disease
Chronic kidney or liver failure
Shock
Contraindications for lipid administration
PN during the 15 days before hospitalisation
No Results Posted