Trials / Completed
CompletedNCT00885781
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- National Taiwan University Hospital · Academic / Other
- Sex
- All
- Age
- 25 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lipid emulsion for TPN | 1-2 g lipid emulsion /kgBW-day, for consecutive 5 days |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2009-04-01
- Completion
- 2010-12-01
- First posted
- 2009-04-22
- Last updated
- 2011-10-17
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT00885781. Inclusion in this directory is not an endorsement.