Gastrectomy, Malnutrition
Conditions
Brief summary
Comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.
Detailed description
The comparison of two lipid emulsion product will be performed. Patients who plan to accept gastrectomy will be consider for trial and signed content will be obtained. If the patient needs total parenteral nutrition (TPN) treatment after surgery for at least 5 days and meets all criteria, then he/she will be enrolled and randomized to ether of the groups, SMOFlipid or Lipovenoes MCT. During the treatment period, efficacy variables and safety variables will be measured. Life quality evaluation will also be performed through questionnaires collection.
Interventions
DRUGlipid emulsion for TPN
1-2 g lipid emulsion /kgBW-day, for consecutive 5 days
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 25 \ 75 years old 2. Postoperative (gastrectomy) patients required parental nutrition for at least 5 days 3. Signed informed consent form
Exclusion criteria
1. Known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients 2. Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia. If the fasting S-triglyceride value at the time of inclusion is \>2.26 mmol/l (\>200 mg/dl) the subject must not be included 3. Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.) 4. Severe renal insufficiency with need for dialysis, chronic stable renal insufficiency defined as S-creatinine value of \>3mg/dL (250 µmol/l), or dialysis/hemofiltration therapy 5. Over weight (BMI\> 30kg/m2) 6. Severe blood coagulation disorders 7. Inborn abnormality in amino acid metabolism 8. Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration) 9. Known diabetic ketoacidosis 7 days prior to randomization. 10. Acute shock 11. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency 12. Pregnancy or lactation 13. Chemotherapy within 7 days before start of the trial 14. Participation in another clinical study with an investigational drug or an investigational medical device within 1 month prior to start of study or during the study 15. Already accept parental nutrition therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence for immunoregulatory effect of lipid emulsion products. | 1-5 days after treatment provided |
Countries
Taiwan
Outcome results
None listed