Control of inflammatory parameters with fish oil in parenteral nutritio

Phase 1

• Conditions: Critically ill adult patients with parenteral nutrition and respiratory infection by SARS-COV-2; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-000705-86-ES
• Lead Sponsor: VALL HEBRON UNIVERSITY HOSPITA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-05
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

•Age = 18 years.
•Patients with at least 5 days of PN.
•Baseline liver parameters before PN: GGT, alkaline phosphatase < 100 U/dL and direct bilirubin <1.2 mg/dL al inicio de NP.
•Liver parameter alterations: GGT = 300 U/dL, alkaline phosphatase = 200 U/dL or direct bilirubin =1.8 mg/dL
•Forseeing to receive at least 5 days of PN.
•Admitted in the ICU of the Valle Hebron University Hospital
•Willing to give their IC in writing for the trial and be able to do so.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 117
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 117

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Infection rate, hyperglycemia rate, hypertrygliceridemia rate, ICU and hospital length of stay. <br>Farnesoid-X receptor expression measured as fibroblast-growth-factor-19.;Timepoint(s) of evaluation of this end point: Day of inclusion and end of P