Liver impairment recovery related to parenteral nutrition with fish oil.

Liver impairment recovery related to parenteral nutrition with omega-3 fatty acids: randomized clinical trial.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003276-39-ES

Enrollment

117

Registered

2019-10-21

Start date

2019-11-12

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill adult patients with parenteral nutrition and liver parameters altered.

Interventions

Trade Name: SMOFLIPID Product Name: TPN with emulsions enriched with omega-3 fatty acid Pharmaceutical Form: Emulsion for infusion INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age = 18 years. • Patients with at least 5 days of PN. • Baseline liver parameters before PN: GGT, alkaline phosphatase =65 years) yes F.1.3.1 Number of subjects for this age range 117

Exclusion criteria

Exclusion criteria: - Lipids administration contraindicated - Have a history of hypersensitivity of idiosincratic reactions to any component of intravenous lipid emulsions. - Home parenteral nutrition patients - Liver transplantation - Liver parameters alterations before PN: 20% above upper normal values. - Patients rejection to participate.

Design outcomes

Primary

Measure	Time frame
Main Objective: In critically adult patients with parenteral nutrition with liver impairment related to parenteral nutrition, the main objective is to determinate wether the change to lipidic emulsion (with a 30% omega-3 fatty acids) is effective in reducing th liver impairment, measured as gamma-glutamyl-transferase (GGT);Secondary Objective: To analyze wether the use of PN with a 30% of omega-3 fatty acids is effective in reducing the infection rate, hyperglycemia rate, hypertrygliceridemia rate, ICU and hospital length of stay. As well as to study the differences in farnesoid-X receptor expression depending on the type of lipid received.;Primary end point(s): Primary end point is the change of liver function parameters: GGT ; from the value the day of inclusion to the end of PN.;Timepoint(s) of evaluation of this end point: Inclusion day and end of PN.	—

Measure

Time frame

Main Objective: In critically adult patients with parenteral nutrition with liver impairment related to parenteral nutrition, the main objective is to determinate wether the change to lipidic emulsion (with a 30% omega-3 fatty acids) is effective in reducing th liver impairment, measured as gamma-glutamyl-transferase (GGT);Secondary Objective: To analyze wether the use of PN with a 30% of omega-3 fatty acids is effective in reducing the infection rate, hyperglycemia rate, hypertrygliceridemia rate, ICU and hospital length of stay. As well as to study the differences in farnesoid-X receptor expression depending on the type of lipid received.;Primary end point(s): Primary end point is the change of liver function parameters: GGT ; from the value the day of inclusion to the end of PN.;Timepoint(s) of evaluation of this end point: Inclusion day and end of PN.

—

Secondary

Measure	Time frame
Secondary end point(s): Infection rate, hyperglycemia rate, hypertrygliceridemia rate, ICU and hospital length of stay. Farnesoid-X receptor expression measured as fibroblast-growth-factor-19. ;Timepoint(s) of evaluation of this end point: Day of inclusion and end of PN	—

Countries

Spain

Contacts

Public ContactDAVID BERLANA

VALL HEBRON UNIVERSITY HOSPITAL

dberlana@vhebron.net+34654431619

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026