Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition

Parenteral Nutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149653
• Other study ID #: NT13236-4/2012
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2017
• Last updated: May 9, 2017
• Start date: January 15, 2012
• Est. completion date: June 30, 2016

Study information

• Verified date: May 2017
• Source: General University Hospital, Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2016
• Est. primary completion date: January 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parenteral Nutrition

Intervention

Drug:
• ClinOleic (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
• ClinOleic + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
• Lipoplus (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
• Lipoplus + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
• SMOFlipid (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
• SMOFlipid + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture

Locations

Country	Name	City	State
Czechia	General University Hospital	Prague

Sponsors (3)

Lead Sponsor	Collaborator
General University Hospital, Prague	Charles University, Czech Republic, Ministry of Health, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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)	day 42, day 70
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Alteration of liver function	Liver function tests	week 6, week 10, week 16, week 20, week 26, week 30
Secondary	Septic complications	Catheter-related bloodstream infections	week 6, week 10, week 16, week 20, week 26, week 30