A Phase 4 interventional study of ClinOleic (baseline) and ClinOleic + Omegaven in Parenteral Nutrition, sponsored by General University Hospital, Prague. Completed at 1 site in Czechia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by General University Hospital, Prague · Phase 4, Interventional, and Treatment
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.
General University Hospital, Prague is the lead sponsor of 37 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.
Drug: ClinOleic (baseline) · Drug: ClinOleic + Omegaven · Drug: Lipoplus (baseline) · Drug: Lipoplus + Omegaven · Drug: SMOFlipid (baseline) · Drug: SMOFlipid + Omegaven
Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.
Drug: ClinOleic (baseline) · Drug: ClinOleic + Omegaven · Drug: Lipoplus (baseline) · Drug: Lipoplus + Omegaven · Drug: SMOFlipid (baseline) · Drug: SMOFlipid + Omegaven
Healthy Control
Lipid emulsion in pharmacy compounded all-in-one admixture
Also known as: ClinOleic 20% Baxter
Lipid emulsion in pharmacy compounded all-in-one admixture
Also known as: ClinOleic 20% Baxter + Omegaven 10% Fresenius Kabi
Lipid emulsion in pharmacy compounded all-in-one admixture
Also known as: Lipoplus 20% BBraun Melsungen
Lipid emulsion in pharmacy compounded all-in-one admixture
Also known as: Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius Kabi
Lipid emulsion in pharmacy compounded all-in-one admixture
Also known as: SMOFlipid 20% Fresenius Kabi
Lipid emulsion in pharmacy compounded all-in-one admixture
Also known as: SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius Kabi
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
Plan to share: No
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General University Hospital, Prague