Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery
Overview
- Phase
- Phase 4
- Sponsor
- Wei Zhou
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- infective complications
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 85 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Contraindications for lipid administration
- •PN during the 15 days before hospitalisation
Arms & Interventions
MCT/LCT
Structural Fat Emulsion Injection 250ml per day, for 7 days
Intervention: MCT/LCT (Drug)
MCT/LCT and fish oil
Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.
Intervention: MCT/LCT and fish oil (Drug)
Outcomes
Primary Outcomes
infective complications
Time Frame: within the first 30 days after surgery
Secondary Outcomes
- length of hospital stay(average of 2 weeks)
- plasma immunological markers(from 1 day before surgery to 7 days after surgery)
Investigators
Wei Zhou
Attending
Sir Run Run Shaw Hospital