Clinical trial NCT00885781: Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrectomy
Malnutrition
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Evidence for immunoregulatory effect of lipid emulsion products.
timeFrame: 1-5 days after treatment provided
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Chief of General Suery department
name: Ming-Tsan Lin, Dr.
role: PRINCIPAL_INVESTIGATOR
References: