Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients (OmegaBurn)

Centro Nacional de Quemados, Uruguay

Status: Unknown

Conditions: Burn Injury

Treatments: Dietary Supplement: Low fat enteral diet; Dietary Supplement: ω-3 PUFA

Study type: Interventional

Funder types: Other

Identifiers

NCT02189538

Universidad de la República

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

ω-3 PUFA

Experimental group

Description:

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

Treatment:

Dietary Supplement: ω-3 PUFA

Low fat enteral diet

Active Comparator group

Description:

Modular low fat (18%)

Treatment:

Dietary Supplement: Low fat enteral diet