Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

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

Tracking Information

• First Submitted Date: April 20, 2009
• First Posted Date: April 22, 2009
• Last Update Posted Date: October 17, 2011
• Study Start Date: November 2008
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 21, 2009): Evidence for immunoregulatory effect of lipid emulsion products. [ Time Frame: 1-5 days after treatment provided ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Gastrectomy
• Malnutrition

Intervention

Drug: lipid emulsion for TPN

1-2 g lipid emulsion /kgBW-day, for consecutive 5 days

Other Name: SMOFlipid 20%

Study Arms

• Experimental: SMOFlipid
  Intervention: Drug: lipid emulsion for TPN
• Active Comparator: Lipovenoes MCT
  Intervention: Drug: lipid emulsion for TPN

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 13, 2011): 40
• Original Estimated Enrollment (submitted: April 21, 2009): 80
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00885781
• Other Study ID Numbers: 200803090M; SMOF-002-I P4
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: National Taiwan University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ming-Tsan Lin, Dr.; Chief of General Suery department

• PRS Account: National Taiwan University Hospital
• Verification Date: May 2011