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Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

Malnutrition Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00885781
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Completed
Phase Phase 4
Start date November 2008
Completion date December 2010
View Details
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