Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT
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
2 other identifiers
interventional
40
1 country
1
Brief Summary
Comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 20, 2009
CompletedFirst Posted
Study publicly available on registry
April 22, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedOctober 17, 2011
May 1, 2011
5 months
April 20, 2009
October 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence for immunoregulatory effect of lipid emulsion products.
1-5 days after treatment provided
Study Arms (2)
SMOFlipid
EXPERIMENTALLipovenoes MCT
ACTIVE COMPARATORInterventions
1-2 g lipid emulsion /kgBW-day, for consecutive 5 days
Eligibility Criteria
You may qualify if:
- Age between 25 \~ 75 years old
- Postoperative (gastrectomy) patients required parental nutrition for at least 5 days
- Signed informed consent form
You may not qualify if:
- Known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients
- Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.)
- 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
- Over weight (BMI\> 30kg/m2)
- Severe blood coagulation disorders
- Inborn abnormality in amino acid metabolism
- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration)
- Known diabetic ketoacidosis 7 days prior to randomization.
- Acute shock
- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
- Pregnancy or lactation
- Chemotherapy within 7 days before start of the trial
- 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
- Already accept parental nutrition therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taipei, 10002, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-Tsan Lin, Dr.
Chief of General Suery department
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2009
First Posted
April 22, 2009
Study Start
November 1, 2008
Primary Completion
April 1, 2009
Study Completion
December 1, 2010
Last Updated
October 17, 2011
Record last verified: 2011-05