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| Name | Class |
|---|---|
| Charles University, Czech Republic | OTHER |
| Ministry of Health, Czech Republic | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Home Parenteral Nutrition, Cross-over | Experimental | 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. |
|
| 2 Home Parenteral Nutrition, Cross-over | Active Comparator | 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. |
|
| Comparator3 | No Intervention | Healthy Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClinOleic (baseline) | Drug | Lipid emulsion in pharmacy compounded all-in-one admixture |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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) | day 42, day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | day 42, day 70 |
| Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frantisek Novak, MD, PhD | General University Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital | Prague | 12808 | Czechia |
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| ClinOleic + Omegaven | Drug | Lipid emulsion in pharmacy compounded all-in-one admixture |
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| Lipoplus (baseline) | Drug | Lipid emulsion in pharmacy compounded all-in-one admixture |
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| Lipoplus + Omegaven | Drug | Lipid emulsion in pharmacy compounded all-in-one admixture |
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| SMOFlipid (baseline) | Drug | Lipid emulsion in pharmacy compounded all-in-one admixture |
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| SMOFlipid + Omegaven | Drug | Lipid emulsion in pharmacy compounded all-in-one admixture |
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The plasma concentration of IL-1-beta (ng/L) |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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%) | 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%) | 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) | 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) | 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) | 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) | 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) | 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) | day 42, day 70 |
| Alteration of liver function | Liver function tests | week 6, week 10, week 16, week 20, week 26, week 30 |
| Septic complications | Catheter-related bloodstream infections | week 6, week 10, week 16, week 20, week 26, week 30 |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C568346 | ClinOleic |
| C074807 | BaseLine dental cement |
| C568345 | fish oil triglycerides |
| C000709826 | SMOFlipid |
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