CLINICAL TRIAL TO COMPARE THE EFFICACY AND SAFETY OF FISH OIL-BASED INTRAVENOUS LIPID EMULSIONS IN HOSPITALIZED ADULT PATIENTS TREATED WITH TOTAL PARENTERAL NUTRITION WITH HIGH TRIGLYCERIDES IN BLOOD

Phase 1

• Conditions: Hypertriglyceridemia is a frequent metabolic complication associated with the administration of lipidic emulsion in total parenteral nutrition.; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-002715-10-ES
• Lead Sponsor: Elisabet Leiva Badosa. Phamacy Department. Hospital Universitari de Bellvitge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Subjects must be 18 years of age or older and may be of both genders and of any race / ethnicity.
2. Subjects must be willing to give written informed consent for the trial and be able to do. Otherwise, it can be done by the legal representative.
3. Subjects should have triglyceride levels between 3 and 4.5 mmol / L and have been treated for at least 1 day with NP.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Subjects may not have a history of type I hypersensitivity or idiosyncratic reactions to any component of lipid emulsions.
2. Women who are pregnant or breast-feeding.
3. Subjects treated with propofol

Study & Design

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