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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease Intervention/treatment Phase
Gastrectomy Malnutrition Drug: lipid emulsion for TPN Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: SMOFlipid

Arms and Interventions
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Arm Intervention/treatment
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%


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885781


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ming-Tsan Lin, Dr. Chief of General Suery department
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00885781    
Other Study ID Numbers: 200803090M
SMOF-002-I P4
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
SMOFlipid
 Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions