Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00885781
First received: April 20, 2009
Last updated: October 13, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Gastrectomy
Malnutrition
Drug: lipid emulsion for TPN
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Evidence for immunoregulatory effect of lipid emulsion products. [ Time Frame: 1-5 days after treatment provided ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMOFlipid Drug: lipid emulsion for TPN
1-2 g lipid emulsion /kgBW-day, for consecutive 5 days
Other Name: SMOFlipid 20%
Active Comparator: Lipovenoes MCT Drug: lipid emulsion for TPN
1-2 g lipid emulsion /kgBW-day, for consecutive 5 days
Other Name: SMOFlipid 20%

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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00885781

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ming-Tsan Lin, Dr. Chief of General Suery department
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00885781     History of Changes
Other Study ID Numbers: 200803090M, SMOF-002-I P4
Study First Received: April 20, 2009
Last Updated: October 13, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 15, 2014