Clinical trial NCT03149653: Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition
Official title: A Prospective, Randomized, Controlled, Double-blind, Crossover-Design, Mono-center, Phase IV Study Comparing the Effect of Omegaven in Combination With Clinoleic or Lipoplus or SMOFlipid in Home Parenteral Nutrition Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parenteral Nutrition
Keywords: lipid emulsion
olive oil
fish oil
intestinal failure
home parenteral nutrition
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
name: Ministry of Health, Czech Republic
First posted: 2017-05-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: Intravenous lipid emulsions (LEs) are an indispensable part of home parenteral nutrition (HPN). All commercially obtainable LEs are applicable for HPN in providing a source of energy and essential fatty acids. The originally used soyabean oil-based LE (Intralipid) have been suspected of being associated with a higher risk of pro-inflammatory lipid-mediator production due to their high content of n-6 polyunsaturated fatty acids. The more modern mixes of soyabean oil, and/or olive oil, and/or fish oil LEs with beneficial responses compared with Intralipid are available. Given that there are no clear clinical recommendations for LE application in HPN, we performed this cross-over design, phase 4 study comparing ClinOleic, Lipoplus or SMOFlipid in chronic intestinal failure patients with additional escalation of fish oil using Omegaven.

Eligibility 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

Primary outcomes:
measure: Change from baseline lipid emulsion production of TNF-alpha after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion production of IL-1-beta after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion production of IL-6 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion production of IL-8 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
Secondary outcomes:
measure: Change from baseline lipid emulsion plasma concentration of TNF-alpha at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration of IL-6 at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration of IL-8 at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration ratio of oxidized LDL/LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration of triglycerides at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration of total cholesterol at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration of HDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration of LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion erythrocyte phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma concentration of fibrothelial growth factor 19 at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion erythrocyte superoxide dismutase activity at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion erythrocyte catalase activity at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion erythrocyte glutathione peroxidase activity at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion erythrocyte glutathione reductase activity at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Change from baseline lipid emulsion plasma paraoxonase 1 activity at 4 weeks of Omegaven lipid emulsion addition
timeFrame: day 42, day 70
measure: Alteration of liver function
timeFrame: week 6, week 10, week 16, week 20, week 26, week 30
measure: Septic complications
timeFrame: week 6, week 10, week 16, week 20, week 26, week 30
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General University Hospital
Study officials:
affiliation: General University Hospital, Prague
name: Frantisek Novak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: