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Completed

NCT Number: NCT03149653

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

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.

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Key information

Conditions

Parenteral Nutrition Digestive System Diseases Gastrointestinal Diseases Hyperphagia Intestinal Diseases Intestinal Failure Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General University Hospital

Prague, 12808, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ClinOleic (baseline)

Drug

Lipid emulsion in pharmacy compounded all-in-one admixture

Other names: ClinOleic 20% Baxter

ClinOleic + Omegaven

Drug

Lipid emulsion in pharmacy compounded all-in-one admixture

Other names: ClinOleic 20% Baxter + Omegaven 10% Fresenius Kabi

Lipoplus (baseline)

Drug

Lipid emulsion in pharmacy compounded all-in-one admixture

Other names: Lipoplus 20% BBraun Melsungen

Lipoplus + Omegaven

Drug

Lipid emulsion in pharmacy compounded all-in-one admixture

Other names: Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius Kabi

SMOFlipid (baseline)

Drug

Lipid emulsion in pharmacy compounded all-in-one admixture

Other names: SMOFlipid 20% Fresenius Kabi

SMOFlipid + Omegaven

Drug

Lipid emulsion in pharmacy compounded all-in-one admixture

Other names: SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius Kabi

Primary outcomes

  1. 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

    Time frame: day 42, day 70

    The whole blood culture supernatant concentration of TNF-alpha (ng/L)

  2. 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

    Time frame: day 42, day 70

    The whole blood culture supernatant concentration of IL-1-beta (ng/L)

  3. 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

    Time frame: day 42, day 70

    The whole blood culture supernatant concentration of IL-6 (ng/L)

  4. 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

    Time frame: day 42, day 70

    The whole blood culture supernatant concentration of IL-8 (ng/L)

Secondary outcomes

  1. Change from baseline lipid emulsion plasma concentration of TNF-alpha at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of TNF-alpha (ng/L)

  2. Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of IL-1-beta (ng/L)

  3. Change from baseline lipid emulsion plasma concentration of IL-6 at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of IL-6 (ng/L)

  4. Change from baseline lipid emulsion plasma concentration of IL-8 at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of IL-8 (ng/L)

  5. Change from baseline lipid emulsion plasma concentration ratio of oxidized LDL/LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration ratio of oxidized LDL/LDL cholesterol (ox-LDL/LDL-C)

  6. Change from baseline lipid emulsion plasma concentration of triglycerides at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of triglycerides (mmol/L)

  7. Change from baseline lipid emulsion plasma concentration of total cholesterol at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of total cholesterol (mmol/L)

  8. Change from baseline lipid emulsion plasma concentration of HDL cholesterol at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of HDL cholesterol (mmol/L)

  9. Change from baseline lipid emulsion plasma concentration of LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of LDL cholesterol (mmol/L)

  10. Change from baseline lipid emulsion plasma phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma phospholipid fatty acid profile (mol%)

  11. Change from baseline lipid emulsion erythrocyte phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The erythrocyte phospholipid fatty acid profile (mol%)

  12. Change from baseline lipid emulsion plasma concentration of fibrothelial growth factor 19 at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma concentration of fibrothelial growth factor 19 (ng/L)

  13. Change from baseline lipid emulsion erythrocyte superoxide dismutase activity at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The erythrocyte activity of SOD (U/g Hb)

  14. Change from baseline lipid emulsion erythrocyte catalase activity at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The erythrocyte activity of CAT (U/g Hb)

  15. Change from baseline lipid emulsion erythrocyte glutathione peroxidase activity at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The erythrocyte activity of GPX (U/g Hb)

  16. Change from baseline lipid emulsion erythrocyte glutathione reductase activity at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The erythrocyte activity of GR (U/g Hb)

  17. Change from baseline lipid emulsion plasma paraoxonase 1 activity at 4 weeks of Omegaven lipid emulsion addition

    Time frame: day 42, day 70

    The plasma activity of PON1 (U/L)

  18. Alteration of liver function

    Time frame: week 6, week 10, week 16, week 20, week 26, week 30

    Liver function tests

  19. Septic complications

    Time frame: week 6, week 10, week 16, week 20, week 26, week 30

    Catheter-related bloodstream infections

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Collaborators

  • Charles University, Czech Republic
  • Ministry of Health, Czech Republic

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 11, 2017
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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