Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

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

Detailed Description
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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.

Official Title
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Clinical Study Comparing Safety and Efficacy of SMOFlipid, the New Generation Fat Emulsion, in Comparison With the Current Fat Emulsion Lipovenoes MCT at the Hospital

Conditions
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Gastrectomy, Malnutrition

Intervention / Treatment
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* Drug: lipid emulsion for TPN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 25   75 years old Postoperative (gastrectomy) patients required parental nutrition for at least 5 days Signed informed consent form Exclusion Criteria: Known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients 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 Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.) 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 Over weight (BMI> 30kg/m2) Severe blood coagulation disorders Inborn abnormality in amino acid metabolism Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration) Known diabetic ketoacidosis 7 days prior to randomization. Acute shock General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency Pregnancy or lactation Chemotherapy within 7 days before start of the trial 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 Already accept parental nutrition therapy.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMOFlipid<br> | Drug: lipid emulsion for TPN<br>* 1-2 g lipid emulsion /kgBW-day, for consecutive 5 days<br>* Other names: SMOFlipid 20%;|
| Active Comparator: Lipovenoes MCT<br> | Drug: lipid emulsion for TPN<br>* 1-2 g lipid emulsion /kgBW-day, for consecutive 5 days<br>* Other names: SMOFlipid 20%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence for immunoregulatory effect of lipid emulsion products. |  | 1-5 days after treatment provided |