Parenteral Nutrition
Conditions
Keywords
lipid emulsion, olive oil, fish oil, intestinal failure, home parenteral nutrition
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.
Interventions
DRUGClinOleic (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
DRUGClinOleic + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
DRUGLipoplus (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
DRUGLipoplus + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
DRUGSMOFlipid (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
DRUGSMOFlipid + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
Sponsors
Charles University, Czech Republic
Ministry of Health, Czech Republic
General University Hospital, Prague
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | day 42, day 70 | The whole blood culture supernatant concentration of TNF-alpha (ng/L) |
| 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 | day 42, day 70 | The whole blood culture supernatant concentration of IL-1-beta (ng/L) |
| 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 | day 42, day 70 | The whole blood culture supernatant concentration of IL-6 (ng/L) |
| 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 | day 42, day 70 | The whole blood culture supernatant concentration of IL-8 (ng/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline lipid emulsion plasma concentration of IL-8 at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of IL-8 (ng/L) |
| Change from baseline lipid emulsion plasma concentration ratio of oxidized LDL/LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration ratio of oxidized LDL/LDL cholesterol (ox-LDL/LDL-C) |
| Change from baseline lipid emulsion plasma concentration of triglycerides at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of triglycerides (mmol/L) |
| Change from baseline lipid emulsion plasma concentration of total cholesterol at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of total cholesterol (mmol/L) |
| Change from baseline lipid emulsion plasma concentration of HDL cholesterol at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of HDL cholesterol (mmol/L) |
| Change from baseline lipid emulsion plasma concentration of LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of LDL cholesterol (mmol/L) |
| Change from baseline lipid emulsion plasma phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma phospholipid fatty acid profile (mol%) |
| Alteration of liver function | week 6, week 10, week 16, week 20, week 26, week 30 | Liver function tests |
| Change from baseline lipid emulsion plasma concentration of fibrothelial growth factor 19 at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of fibrothelial growth factor 19 (ng/L) |
| Change from baseline lipid emulsion erythrocyte superoxide dismutase activity at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The erythrocyte activity of SOD (U/g Hb) |
| Change from baseline lipid emulsion erythrocyte catalase activity at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The erythrocyte activity of CAT (U/g Hb) |
| Change from baseline lipid emulsion erythrocyte glutathione peroxidase activity at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The erythrocyte activity of GPX (U/g Hb) |
| Change from baseline lipid emulsion erythrocyte glutathione reductase activity at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The erythrocyte activity of GR (U/g Hb) |
| Change from baseline lipid emulsion plasma paraoxonase 1 activity at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma activity of PON1 (U/L) |
| Septic complications | week 6, week 10, week 16, week 20, week 26, week 30 | Catheter-related bloodstream infections |
| Change from baseline lipid emulsion erythrocyte phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The erythrocyte phospholipid fatty acid profile (mol%) |
| Change from baseline lipid emulsion plasma concentration of TNF-alpha at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of TNF-alpha (ng/L) |
| Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of IL-1-beta (ng/L) |
| Change from baseline lipid emulsion plasma concentration of IL-6 at 4 weeks of Omegaven lipid emulsion addition | day 42, day 70 | The plasma concentration of IL-6 (ng/L) |
Countries
Czechia
Outcome results
None listed