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Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

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ClinicalTrials.gov Identifier: NCT00885781
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : October 17, 2011
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE April 20, 2009
First Posted Date  ICMJE April 22, 2009
Last Update Posted Date October 17, 2011
Study Start Date  ICMJE November 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
Evidence for immunoregulatory effect of lipid emulsion products. [ Time Frame: 1-5 days after treatment provided ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Gastrectomy
  • Malnutrition
Intervention  ICMJE Drug: lipid emulsion for TPN
1-2 g lipid emulsion /kgBW-day, for consecutive 5 days
Other Name: SMOFlipid 20%
Study Arms  ICMJE
  • Experimental: SMOFlipid
    Intervention: Drug: lipid emulsion for TPN
  • Active Comparator: Lipovenoes MCT
    Intervention: Drug: lipid emulsion for TPN
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2009)
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00885781
Other Study ID Numbers  ICMJE 200803090M
SMOF-002-I P4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Taiwan University Hospital
Original Responsible Party Ming-Tsan Lin/ Chief of General Surgery Department, National Taiwan University Hospital
Current Study Sponsor  ICMJE National Taiwan University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ming-Tsan Lin, Dr. Chief of General Suery department
PRS Account National Taiwan University Hospital
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP