Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: SMOFlipid

Criteria

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.