Trial | NCT02189538  Report issue

Title

Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients
Effect of Omega-3 PUFA From Fish in Major Burn Patients. EFECTO DE ÁCIDOS GRASOS POLIINSATURADOS OMEGA 3 DERIVADOS DE ACEITE DE PESCADO, EN QUEMADOS GRAVES

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    100
Studies have shown that burn patients may benefit from low fat diets, but there is still no strong data regarding the impact of fatty acid composition used for feeding. The trial test the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome. Prospective randomised controlled trial in adult patients admitted for burns > 15% body surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study endpoints: mechanical ventilation time, inflammation (CRP), infectious and other complications, mortality until discharge.

The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2) the study completed with information from the preliminary phase, both phases being randomised and controlled.
Randomisation within the first 24 hours of admission to 2 types of enteral feeds: 1) ω 3 PUFA (FO-EN) or 2) control solution which is the hospitals standard low 18% fat containing solution.

The patients are fed as long as clinically required with the initial solution.
Study Started
Jan 31
2013
Primary Completion
Dec 31
2017
Anticipated
Study Completion
Feb 28
2018
Anticipated
Last Update
Feb 15
2017

Dietary Supplement ω-3 PUFA

The patients are fed as long as the clinically required with the randomly attributed enteral solution.

  • Other names: modular preparation: 9% ω-3 of the total 18% fat

Dietary Supplement Low fat enteral diet

The patients are fed as long as the clinically required with the randomly attributed enteral solution

  • Other names: modular diet

ω-3 PUFA Experimental

Modular low fat diet (18%) including 9% as ω-3 PUFA

Low fat enteral diet Active Comparator

Modular low fat (18%)

Criteria 

Inclusion Criteria:

- adult >16 years, burns > 15% BSA, mechanical ventilation, next of kin consent

Exclusion Criteria:

absence of the above, absence of commitment to full treatment
comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)
pregnancy
No Results Posted