Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition

• Status: Completed
• Trial end date: 2016-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events. We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients. The non-interventional group of healthy controls was included for comparison.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: General University Hospital, Prague
• Collaborators: Charles University, Czech Republic; Ministry of Health, Czech Republic
• Treatments: SMOFlipid

Criteria

Inclusion Criteria:

• Home parenteral nutrition patients in need of parenteral nutrition administration > 4 days/week

• Parenteral duration expectancy > 8 months

• Stable clinical condition without any complications in the past 2 months

• Written consent from the subject

Exclusion Criteria:

• Known hypersensitivity to any of the active substances or excipients

• Unstable conditions

• Active cancer or its treatment

• Established immunodeficiency

• Advanced organ dysfunction from chronic disease