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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Lipid emulsion in pharmacy compounded all-in-one admixture
Lipid emulsion in pharmacy compounded all-in-one admixture
Lipid emulsion in pharmacy compounded all-in-one admixture
Lipid emulsion in pharmacy compounded all-in-one admixture
Lipid emulsion in pharmacy compounded all-in-one admixture
Lipid emulsion in pharmacy compounded all-in-one admixture
General University Hospital
Prague, Czechia
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
The whole blood culture supernatant concentration of TNF-alpha (ng/L)
Time frame: day 42, day 70
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
The whole blood culture supernatant concentration of IL-1-beta (ng/L)
Time frame: day 42, day 70
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
The whole blood culture supernatant concentration of IL-6 (ng/L)
Time frame: day 42, day 70
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
The whole blood culture supernatant concentration of IL-8 (ng/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of TNF-alpha at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of TNF-alpha (ng/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of IL-1-beta (ng/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-6 at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of IL-6 (ng/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-8 at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of IL-8 (ng/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration ratio of oxidized LDL/LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration ratio of oxidized LDL/LDL cholesterol (ox-LDL/LDL-C)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of triglycerides at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of triglycerides (mmol/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of total cholesterol at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of total cholesterol (mmol/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of HDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of HDL cholesterol (mmol/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of LDL cholesterol (mmol/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
The plasma phospholipid fatty acid profile (mol%)
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte phospholipid fatty acid profile (mol%)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of fibrothelial growth factor 19 at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of fibrothelial growth factor 19 (ng/L)
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte superoxide dismutase activity at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte activity of SOD (U/g Hb)
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte catalase activity at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte activity of CAT (U/g Hb)
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte glutathione peroxidase activity at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte activity of GPX (U/g Hb)
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte glutathione reductase activity at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte activity of GR (U/g Hb)
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma paraoxonase 1 activity at 4 weeks of Omegaven lipid emulsion addition
The plasma activity of PON1 (U/L)
Time frame: day 42, day 70
Alteration of liver function
Liver function tests
Time frame: week 6, week 10, week 16, week 20, week 26, week 30
Septic complications
Catheter-related bloodstream infections
Time frame: week 6, week 10, week 16, week 20, week 26, week 30
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